Dressing, Wound, Drug
A drug wound dressing is a wound care product that incorporates a pharmaceutical agent intended to promote healing, prevent infection, or manage wound exudate. This product is currently unclassified by the FDA, meaning its classification has not been finalized; it is under review by the General, Plastic Surgery panel. The product code is FRO and no regulation number has been assigned. No special flags apply to this device.
Basic Information
- Product Code
- FRO
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 862 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251093 | Bonvadis® | Jun 09, 2025 | Substantially Equivalent | Oneness Biotech Co., Ltd. |
| K243457 | Nixall Antimicrobial Solutions Skin & Wound Hydrogel | May 02, 2025 | Substantially Equivalent | Seriously Clean, Ltd |
| K243875 | Spectricept Skin and Wound Cleanser | Apr 21, 2025 | Substantially Equivalent | Spectrum Antimicrobials, Inc. |
| K242406 | SiOxC Cream | Mar 13, 2025 | Substantially Equivalent | SiOxMed, LLC |
| K243001 | Sterile Water USP and Sterile 0.9% Normal Saline USP | Mar 06, 2025 | Substantially Equivalent | Laboratorios Biogalenic S.A. DE C.V, |
| K240809 | LUOFUCON® Silver Collagen Dressing | Dec 16, 2024 | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. |
| K242758 | Atrauman® Ag | Dec 09, 2024 | Substantially Equivalent | Hartmann USA, Inc. |
| K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) | Nov 13, 2024 | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. |
| K240510 | Microdacyn Hydrogel | Nov 08, 2024 | Substantially Equivalent | Sonoma Pharmaceuticals, Inc. |
| K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo | Oct 31, 2024 | Substantially Equivalent | Bionova Medical, Inc. |
| K222740 | Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch | Oct 21, 2024 | Substantially Equivalent | Speciality Fibres and Materials Ltd. |
| K211943 | Microlyte Ag/Lidocaine | Oct 17, 2024 | Substantially Equivalent | Imbed Biosciences |
| K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) | Oct 07, 2024 | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. |
| K240722 | Derma-R Cream (Derma-R Cream) | Sep 20, 2024 | Substantially Equivalent | Raya Pharmaceuticals LLC |
| K233399 | Microdacyn Wound Care Solution | Sep 13, 2024 | Substantially Equivalent | Sonoma Pharmaceuticals, Inc. |
| K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Aug 21, 2024 | Substantially Equivalent | Bionova Medical, Inc. |
| K241225 | Silverlon® Wound Contact, Burn Contact Dressing | Jul 31, 2024 | Substantially Equivalent | Argentum Medical LLC |
| K241809 | coactiv+ Antimicrobial Wound Gel | Jul 19, 2024 | Substantially Equivalent | Kane Biotech, Inc. |
| K212521 | Field Shield Wound Dressing | Jul 18, 2024 | Substantially Equivalent | Kericure Inc. |
| K241660 | SiOxD® Wound Matrix | Jul 05, 2024 | Substantially Equivalent | SiOxMed, LLC |
| K240552 | Irrisept Antimicrobial Wound Lavage | Jun 18, 2024 | Substantially Equivalent | Irrimax Corporation |
| K232333 | Anti-bacterial bandage | May 31, 2024 | Substantially Equivalent | Jinhua Jingdi Medical Supplies Co., Ltd. |
| K232080 | Puracyn® Plus Antimicrobial Irrigation Solution | May 31, 2024 | Substantially Equivalent | Innovacyn, Inc. |
| K233111 | ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC | May 24, 2024 | Substantially Equivalent | Foshan United Medical Technologies, Ltd. |
| K232655 | Bonvadis® | May 22, 2024 | Substantially Equivalent | StemCyte Inc. |
| K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing | Mar 27, 2024 | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. |
| K233151 | PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) | Mar 26, 2024 | Substantially Equivalent | Medline Industries, LP |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in) | Mar 22, 2024 | Substantially Equivalent | Coloplast Corp. |
| K231088 | Copper Foam Dressing (Prescription and OTC) | Jan 11, 2024 | Substantially Equivalent | Roosin Medical Co., Ltd. |
| K221110 | LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing | Jan 04, 2024 | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. |
| K223359 | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing | Dec 21, 2023 | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. |
| K232847 | SiOxD Wound Matrix | Dec 18, 2023 | Substantially Equivalent | SiOxMed, LLC. |
| K231057 | Antibacterial Gel Wound Dressing | Dec 01, 2023 | Substantially Equivalent | Winner Medical Co., Ltd. |
| K230190 | Polyver Silver Alginate Dressing (Prescription and OTC) | Nov 17, 2023 | Substantially Equivalent | Roosin Medical Co., Ltd. |
| K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Nov 13, 2023 | Substantially Equivalent | Bionova Medical, Inc. |
| K231564 | Skin and Wound Cleanser | Nov 10, 2023 | Substantially Equivalent | Winner Medical Co., Ltd. |
| K213473 | Antimicrobial Gelling Fiber Dressing with PHMB | Oct 26, 2023 | Substantially Equivalent | Advanced Medical Solutions Ltd. |
| K222143 | APIS (R), VERIS (TM) | Oct 13, 2023 | Substantially Equivalent | SweetBio, Inc |
| K222025 | G4Derm / G4Derm Plus Synthetic Wound Matrix | Oct 11, 2023 | Substantially Equivalent | Gel4Med, Inc. |
| K221570 | Antibacterial bandage | Sep 29, 2023 | Substantially Equivalent | Allmed Medical Products Co., Ltd. |
| K213413 | Hemostatic Dressing | Sep 01, 2023 | Substantially Equivalent | Jiangsu NewValue Medical Products Co., Ltd. |
| K212766 | Maxiocel Chitosan Wound Dressing | Aug 24, 2023 | Substantially Equivalent | Advamedica Inc. |
| K223526 | ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing | Aug 18, 2023 | Substantially Equivalent | Smith & Nephew Medical Limited |
| K213652 | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) | Jun 28, 2023 | Substantially Equivalent | Cresilon, Inc. |
| K221311 | Antibacterial Bandage | Jun 21, 2023 | Substantially Equivalent | Winner Medical Co., Ltd. |
| K223259 | coactiv+ Antimicrobial Wound Gel | May 24, 2023 | Substantially Equivalent | Kane Biotech, Inc. |
| K223725 | Restrata® MiniMatrix | May 18, 2023 | Substantially Equivalent | Acera Surgical, Inc. |
| K223495 | Zeolite Hemostatic Cotton | May 02, 2023 | Substantially Equivalent | Hangzhou Zeo-Innov Life Technology Co., Ltd |
| K222909 | Axiostat Gauze | Apr 07, 2023 | Substantially Equivalent | Advamedica Inc. |
| K223310 | Antimicrobial Silicone PHMB Foam Wound Dressing | Apr 05, 2023 | Substantially Equivalent | Advanced Medical Solutions Limited |
| K223377 | BIASURGE Advanced Surgical Solution | Mar 30, 2023 | Substantially Equivalent | Rochal Technologies LLC |
| K220673 | Sterile Silver Alginate Wound Dressing | Mar 16, 2023 | Substantially Equivalent | Qingdao Bright Moon Biomedical Materials Co., Ltd. |
| K210751 | S.E.A.L. Hemostatic Wound Spray | Feb 02, 2023 | Substantially Equivalent | BC3 Technologies Inc |
| K221532 | PHMB Wound Dressing | Jan 30, 2023 | Substantially Equivalent | Winner Medical Co., Ltd. |
| K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) | Jan 17, 2023 | Substantially Equivalent | Winner Medical Co., Ltd. |
| K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing | Jan 13, 2023 | Substantially Equivalent | Winner Medical Co., Ltd. |
| K213514 | Spectricept Skin and Wound Cleanser | Jan 13, 2023 | Substantially Equivalent | Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. |
| K221720 | Extra Silver Gelling Fiber Dressing | Dec 21, 2022 | Substantially Equivalent | Winner Medical Co., Ltd. |
| K220286 | ELECTROCYN soma | Dec 21, 2022 | Substantially Equivalent | V3bio Sdn. Bhd |
| K222189 | SiOxD Wound Matrix | Nov 18, 2022 | Substantially Equivalent | SiOxMed, LLC. |
| K221218 | Silverlon Wound Contact, Burn Contact Dressings | Oct 26, 2022 | Substantially Equivalent | Argentum Medical, Inc. |
| K222657 | MEBO Wound Dressing | Oct 18, 2022 | Substantially Equivalent | MEBO Life Science Inc. |
| K212554 | Bonvadis Topical Cream | Aug 19, 2022 | Substantially Equivalent | StemCyte Inc. |
| K210949 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Aug 11, 2022 | Substantially Equivalent | Bionova Medical Inc. |
| K220566 | Vascette HP (hemostatic pad) | Jul 29, 2022 | Substantially Equivalent | KOAG LLC |
| K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel | Apr 22, 2022 | Substantially Equivalent | Huizhou Foryou Medical Devices CO., Ltd. |
| K210718 | LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing | Mar 23, 2022 | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. |
| K210135 | PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing | Feb 24, 2022 | Substantially Equivalent | 3M Health Care Business Group |
| K210466 | Silver Gelling Fiber Dressing | Jan 14, 2022 | Substantially Equivalent | Winner Medical Co., Ltd. |
| K202982 | Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) | Oct 19, 2021 | Substantially Equivalent | Winner Medical Co., Ltd. |
| K203446 | TorrentX Wound Wash | Sep 23, 2021 | Substantially Equivalent | Next Science, LLC |
| K211972 | Omeza Collagen Matrix | Sep 01, 2021 | Substantially Equivalent | Omeza, LLC |
| K210974 | High Performance Antimicrobial Gelling Fiber with Silver | May 12, 2021 | Substantially Equivalent | Advanced Medical Solutions Ltd. |
| K203835 | MIS Solution | Apr 23, 2021 | Substantially Equivalent | Next Science, LLC |
| K201138 | AMSure® Single Use Saline Topical Solution | Apr 14, 2021 | Substantially Equivalent | Amsino Medical Inc. |
| K201324 | Antibacterial Bandage | Feb 05, 2021 | Substantially Equivalent | Jiangsu Excellence Medical Supplies Co., Ltd |
| K201016 | LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) | Jan 28, 2021 | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. |
| K200821 | anti-bacterial bandage | Oct 19, 2020 | Substantially Equivalent | Planet (Suzhou) Medical Products Co., Ltd |
| K200767 | SilverStream Gel | Oct 08, 2020 | Substantially Equivalent | EnzySurge Ltd. |
| K200835 | 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad | Sep 04, 2020 | Substantially Equivalent | 3M Company |
| K193439 | MEBO Wound Dressing | Sep 04, 2020 | Substantially Equivalent | MEBO Life Science Inc. |
| K200641 | HaloGUARD Protective Disc with CHG | Sep 03, 2020 | Substantially Equivalent | ATTWILL Medical Solutions |
| K192478 | LT Antibacterial Alginate with Silver Dressing | Jun 17, 2020 | Substantially Equivalent | Zhejiang Longterm Medical Technology Co., Ltd. |
| K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border | May 14, 2020 | Substantially Equivalent | Winner Medical Co., Ltd. |
| K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border | May 14, 2020 | Substantially Equivalent | Winner Medical Co., Ltd. |
| K193085 | PuraDERM Gel | May 11, 2020 | Substantially Equivalent | 3-D Matrix, Inc. |
| K190129 | AC5 Topical Gel | Mar 11, 2020 | Substantially Equivalent | Arch Therapeutics, Inc. |
| K191536 | Biatain Silicone Ag | Feb 21, 2020 | Substantially Equivalent | Coloplast A/S |
| K192527 | Rochal Antimicrobial Wound Gel | Feb 07, 2020 | Substantially Equivalent | Rochal Industries, LLC |
| K190756 | IODOFLEX | Dec 20, 2019 | Substantially Equivalent | Smith & Nephew Medical Ltd. |
| K190730 | IODOSORB | Dec 20, 2019 | Substantially Equivalent | Smith & Nephew Medical Ltd. |
| K190268 | Hydrofera Blue READY - Border | Nov 06, 2019 | Substantially Equivalent | Hydrofera, LLC |
| K190342 | BIAFINE Topical Cream | Oct 18, 2019 | Substantially Equivalent | Bausch Health Americas Incorporated |
| K183681 | Protego Antimicrobial Wound Dressing | Oct 11, 2019 | Substantially Equivalent | Global Health Solutions (DBA Turn Therapeutics) |
| K181428 | Clyra Wound Irrigation Solution | Sep 20, 2019 | Substantially Equivalent | Clyra Medical Technologies Inc. |
| K181478 | Roosin Xeroform Petrolatum Dressing | Sep 13, 2019 | Substantially Equivalent | Roosin Medical Co., Ltd |
| K183662 | Saline Wound Wash, SteriCleanse(TM) | Sep 12, 2019 | Substantially Equivalent | Ascent Consumer Products, Inc. |
| K183208 | Suprasorb A + Ag R | Aug 15, 2019 | Substantially Equivalent | Speciality Fibres and Materials Ltd. |
| K190819 | Silicone PHMB Foam Wound Dressing | Jul 25, 2019 | Substantially Equivalent | Advanced Medical Solutions Ltd. |
| K190343 | Silverlon Wound Contact, Burn Contact Dressings | Jul 18, 2019 | Substantially Equivalent | Argentum Medical, LLC |
| K182725 | Apis | May 31, 2019 | Substantially Equivalent | SweetBio, Inc |
| K183645 | Silver High Performance Dressing | May 29, 2019 | Substantially Equivalent | Advanced Medical Solutions Ltd. |
| K190224 | Medline Burn and Wound Dressing (OTC) | Mar 08, 2019 | Substantially Equivalent | Medline Industries, Inc. |
| K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing | Feb 14, 2019 | Substantially Equivalent | Winner Medical Co., Ltd |
| K180570 | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) | Jan 14, 2019 | Substantially Equivalent | Argentum Medical, LLC |
| K182681 | AC5 Topical Gel | Dec 14, 2018 | Substantially Equivalent | Arch Therapeutics, Inc. |
| K180533 | Procellera Composite Antibacterial Wound Dressing | Dec 10, 2018 | Substantially Equivalent | Vomaris Wound Care, Inc. |
| K182680 | KerraContact Ag Perf Advanced Perforated Silver Wound Dressing | Dec 06, 2018 | Substantially Equivalent | Exciton Technologies, Inc. |
| K180643 | MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) | Nov 23, 2018 | Substantially Equivalent | MedCu Technologies, Ltd. |
| K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound Flush | Sep 07, 2018 | Substantially Equivalent | Amsino International Inc. |
| K181074 | Simple Science Antimicrobial Facial and Eyelid Cleanser | Aug 17, 2018 | Substantially Equivalent | Simple Science LLC |
| K173549 | BIAFINE | Aug 13, 2018 | Substantially Equivalent | Valeant Pharmaceuticals |
| K173844 | Titan Ag 200 | Aug 09, 2018 | Substantially Equivalent | Specialty Fibres and Materials Ltd |
| K180634 | Surgical Silver Post Operative Dressing | Aug 07, 2018 | Substantially Equivalent | Advanced Medical Solutions Ltd. |
| K181197 | PHMB Foam Wound Dressing | Aug 03, 2018 | Substantially Equivalent | Advanced Medical Solutions Ltd. |
| K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber | Jul 20, 2018 | Substantially Equivalent | ConvaTec Limited |
| K173911 | Medline Burn and Wound Dressing | Jul 19, 2018 | Substantially Equivalent | Medline Industries, Inc. |
| K173276 | Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP | Jul 02, 2018 | Substantially Equivalent | Medline Industries, Inc. |
| K173005 | SURECELL Gelling Fiber Wound Dressing | May 25, 2018 | Substantially Equivalent | Jiangsu Newvalue Medical Producst Co.,Ltd |
| K172570 | ALGS6 Ag Alginate Wound Dressing | May 11, 2018 | Substantially Equivalent | Foshan United Medical Technologies, Ltd. |
| K172554 | LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing | May 01, 2018 | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. |
| K172747 | HYALURONIC ACID TOPICAL WOUND CREAM | Apr 27, 2018 | Substantially Equivalent | VIRCHOW BIOTECH PVT LTD |
| K180305 | Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) | Apr 13, 2018 | Substantially Equivalent | Aquilabs US LLC |
| K173072 | Algidex Ag Silver Alginate Wound Dressing | Apr 04, 2018 | Substantially Equivalent | DeRoyal Industries, Inc. |
| K173896 | Microcyn Antimicrobial Hydrogel | Apr 02, 2018 | Substantially Equivalent | Sonoma Pharmaceuticals, Inc. |
| K172338 | Catasyn Advanced Technology Wound Hydrogel | Feb 21, 2018 | Substantially Equivalent | Synedgen, Inc |
| K172010 | gel-e Bandage | Dec 07, 2017 | Substantially Equivalent | gel-e, Inc. (formerly Remedium Technologies, Inc.) |
| K171935 | Alevicyn SG Antimicrobial Gel | Dec 01, 2017 | Substantially Equivalent | Sonoma Pharmaceuticals, Inc. |
| K172622 | Microcyn Antimicrobial Skin and Wound Cleanser | Nov 21, 2017 | Substantially Equivalent | Sonoma Pharmaceuticals |
| K170754 | 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing | Nov 21, 2017 | Substantially Equivalent | 3M Company, 3M Health Care |
| K172318 | Endoform Silver Dermal Template | Nov 17, 2017 | Substantially Equivalent | Aroa Biosurgery |
| K172851 | Microcyn Plus Antimicrobial Wound Care Solution | Nov 15, 2017 | Substantially Equivalent | Sonoma Pharmaceuticals, Inc. |
| K172486 | Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle | Sep 21, 2017 | Substantially Equivalent | Anexa Biomedical, Inc. |
| K171191 | Hexagen Derm | Aug 25, 2017 | Substantially Equivalent | Global Health Solutions, LLC |
| K171041 | SilverSeal | Aug 22, 2017 | Substantially Equivalent | Alliqua BioMedical, Inc |
| K170911 | NEOCERA Advanced Barrier Cream | Aug 22, 2017 | Substantially Equivalent | EXELTIS USA Dermatology, LLC |
| K171225 | Sorbact Wound Dressing-Ribbon Gauze | Aug 21, 2017 | Substantially Equivalent | ABIGO Medical AB |
| K171727 | Hydrocleanse Antimicrobial Skin and Wound Care Solution | Jul 26, 2017 | Substantially Equivalent | Sonoma Pharmaceuticals |
| K163062 | PHMB Antimicrobial Foam Wound Dressing | Jul 25, 2017 | Substantially Equivalent | Advanced Medical Solutions Ltd. |
| K170407 | BD ChloraShield IV Dressing with CHG Antimicrobial | Jul 17, 2017 | Substantially Equivalent | Avery Dennison Belgie BVBA |
| K171908 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | Jul 11, 2017 | Substantially Equivalent | 3M Company |
| K170270 | Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline | Jun 23, 2017 | Substantially Equivalent | LS Scientific Inc. D.B.A. KSE Scientific |
| K153138 | Cerdak Basic | Jun 23, 2017 | Substantially Equivalent | BU POLYSCIENCES EQUIPMENT & TRADING, LLC |
| K163430 | Prontosan Wound Gel | May 23, 2017 | Substantially Equivalent | B. Braun Medical, Inc. |
| K153410 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | May 15, 2017 | Substantially Equivalent | 3M COMPANY |
| K162017 | Ross Ru Wound Dressing Gel | Apr 20, 2017 | Substantially Equivalent | BIOTD, S.A. |
| K170077 | LUOFUCON Silicone Ag Foam Dressing with Border | Mar 30, 2017 | Substantially Equivalent | HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. |
| K163529 | ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) | Mar 29, 2017 | Substantially Equivalent | AVERY DENNISON CORPORATION |
| K162217 | LOYON | Mar 23, 2017 | Substantially Equivalent | Oculus Innovative Sciences |
| K163188 | Next Science Wound Gel (Rx) | Mar 06, 2017 | Substantially Equivalent | Next Science, LLC |
| K161991 | Curasite | Mar 03, 2017 | Substantially Equivalent | IZUN PHARMACEUTICALS |
| K162508 | KerraCel Ag Gelling Fiber Silver Dressing | Feb 13, 2017 | Substantially Equivalent | Exciton Technologies Inc. |
| K160695 | Talymed Suspension | Dec 06, 2016 | Substantially Equivalent | Marine Polymer Technologies, Inc. |
| K160872 | PolyPlex Wound Dressing | Nov 23, 2016 | Substantially Equivalent | GLOBAL HEALTH SOLUTIONS, LLC |
| K161623 | Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL | Nov 10, 2016 | Substantially Equivalent | B. Braun Medical Inc. |
| K152533 | Xonrid Gel | Oct 28, 2016 | Substantially Equivalent | Helsinn Healthcare SA |
| K152970 | Dynarex Xeroform Petrolatum Dressing | Oct 03, 2016 | Substantially Equivalent | DYNAREX CORPORATION |
| K161212 | Atteris Antimicrobial Skin Protectant | Sep 30, 2016 | Substantially Equivalent | ROCHAL INDUSTRIES LLC |
| K153565 | DONASORB SILVER WOUND DRESSING | Sep 22, 2016 | Substantially Equivalent | VIRCHOW BIOTECH PVT. LTD. |
| K161658 | Anexa Wound Flush, Sterile Water & Sterile Normal Saline | Sep 14, 2016 | Substantially Equivalent | ANEXA BIOMEDICAL, INC. |
| K153723 | ACTICOAT Surgical Dressing | Sep 14, 2016 | Substantially Equivalent | Smith & Nephew Medical Limited |
| K160783 | Procellera | Sep 07, 2016 | Substantially Equivalent | VOMARIS INNOVATIONS, INC. |
| K161311 | USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles | Aug 29, 2016 | Substantially Equivalent | STRUKMYER MEDICAL LLC |
| K160379 | Exufiber Ag+ | Aug 25, 2016 | Substantially Equivalent | MOLNLYCKE HEALTH CARE, US LLC |
| K161034 | Microcyn Plus Wound Care Solution | Aug 19, 2016 | Substantially Equivalent | OCULUS INNOVATIVE SCIENCES |
| K160022 | LUOFUCON Silicone Ag foam dressing | Aug 17, 2016 | Substantially Equivalent | HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. |
| K153678 | PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove | Aug 08, 2016 | Substantially Equivalent | PERMEADERM, INC. |
| K153756 | Microlyte Ag | Aug 04, 2016 | Substantially Equivalent | IMBED BIOSCIENCES, INC. |
| K161289 | DURAFIBER Ag | Aug 03, 2016 | Substantially Equivalent | SMITH & NEPHEW MEDICAL LIMITED |
| K160192 | Atteris Antimicrobial Skin & Wound Cleanser | Jul 28, 2016 | Substantially Equivalent | ROCHAL INDUSTRIES LLC |
| K150208 | Dakin's Skin and Wound Cleanser | Jul 21, 2016 | Substantially Equivalent | CENTURY PHARMACEUTICALS, INC. |
| K153674 | Sorbact Foam Gentle Border, Sorbact Superabsorbent | Jul 01, 2016 | Substantially Equivalent | ABIGO Medical AB |
| K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz | Jun 10, 2016 | Substantially Equivalent | Simple Science, LLC |
| K152519 | MTR550 (Tentative) Antimicrobial Silver Wound Gel | Jun 02, 2016 | Substantially Equivalent | MEDICAL TECHNOLOGY RESEARCH INC. |
| K152544 | Agem Ag Mesh Dressing with Silver | May 23, 2016 | Substantially Equivalent | SHENZHEN YUANXING NANO-PHARMA CO., LTD |
| K150914 | Dash-Topic Plus Cream | Apr 21, 2016 | Substantially Equivalent | Founders Science Group, LLC |
| K153648 | Microcyn Plus Skin and Wound Hydrogel | Apr 19, 2016 | Substantially Equivalent | OCULUS INNOVATIVE SCIENCES |
| K143605 | Nutraseb Facial Cream | Apr 14, 2016 | Substantially Equivalent | ISDIN Corp |
| K151185 | AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) | Feb 05, 2016 | Substantially Equivalent | ABL Medical, LLC |
| K152926 | AQUACEL Ag Surgical SP Dressing | Jan 21, 2016 | Substantially Equivalent | CONVATEC LIMITED |
| K150676 | L-Mesitran Dressing Family II- Soft and Tulle | Dec 23, 2015 | Substantially Equivalent | Theo Manufacturing BV |
| K151168 | Nexodyn AOS Wound Care Solution | Dec 22, 2015 | Substantially Equivalent | APR Applied Pharma Research SA |
| K150792 | Next Science Wound Gel | Dec 17, 2015 | Substantially Equivalent | NEXT SCIENCE, LLC |
| K152945 | Alevicyn SG Antipruritic Gel | Dec 15, 2015 | Substantially Equivalent | OCULUS INNOVATIVE SCIENCES |
| K151186 | Stay Fresh Hydrocolloid dressing | Nov 27, 2015 | Substantially Equivalent | SARASOTA MEDICAL PRODUCTS, INC. |
| K152055 | Ceramax Skin Barrier Cream | Nov 23, 2015 | Substantially Equivalent | OCULUS INNOVATIVE SCIENCES |
| K150985 | Medihoney Wound Gel | Nov 19, 2015 | Substantially Equivalent | DERMA SCIENCES, INC. |
| K150799 | Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula | Nov 19, 2015 | Substantially Equivalent | INNOVACYN, INC. |
| K152923 | BD ChloraShield IV Dressing with CHG Antimicrobial | Nov 05, 2015 | Substantially Equivalent | AVERY DENNISON BELGIE BVBA |
| K142592 | CleanSmart Wound Cleanser | Sep 02, 2015 | Substantially Equivalent | SIMPLE SCIENCE, LLC |
| K143444 | SynePure Wound Cleanser | Aug 21, 2015 | Substantially Equivalent | Synedgen Inc. |
| K143017 | Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver | Aug 07, 2015 | Substantially Equivalent | LABORATOIRES URGO |
| K142962 | PROTOCOL Incision Dressing | Jul 23, 2015 | Substantially Equivalent | DEROYAL INDUSTRIES |
| K133279 | MEDIHONEY WOUND DRESSINGS | Jun 25, 2015 | Substantially Equivalent | DERMA SCIENCES, INC. |
| K143590 | Alevicyn SG Antipruritic Gel | Jun 04, 2015 | Substantially Equivalent | OCULUS INNOVATIVE SCIENCES |
| K141637 | SPB SKIN EMULSION | Jun 03, 2015 | Substantially Equivalent | BIOTD, S.A. |
| K143335 | Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) | Jun 01, 2015 | Substantially Equivalent | Roosin Medical Devices Co., Ltd |
| K141863 | PURICORE WOUND HYDROGEL SPRAY DRESSING | May 14, 2015 | Substantially Equivalent | PURICORE INC. |
| K140905 | DERMAFINE | May 08, 2015 | Substantially Equivalent | INVADO PHARMACEUTICALS |
| K150256 | SILVERLON BURN CONTACT DRESSINGS | Apr 30, 2015 | Substantially Equivalent | ARGENTUM MEDICAL |
| K143527 | IPM Wound Gel Bio, IPM Derm Gel Bio | Apr 20, 2015 | Substantially Equivalent | GLYCOBIOSCIENCES, INC |
| K141619 | LUOFUCON SILVER FOAM DRESSING | Apr 06, 2015 | Substantially Equivalent | HUIZHOU FORYOU MEDICAL DEVICES CO, LTD |
| K140954 | LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING | Mar 23, 2015 | Substantially Equivalent | HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. |
| K143058 | PuraDerm Gel | Feb 13, 2015 | Substantially Equivalent | 3-D Matrix, Inc. |
| K142775 | Neuwater TM (HydrocynTM aqua) | Feb 13, 2015 | Substantially Equivalent | Vigilenz Medical Devices |
| K141382 | BIOS KING BIOCELLULOSE FILM | Feb 10, 2015 | Substantially Equivalent | CORELEADER BIOTECH CO., LTD. |
| K143151 | Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) | Jan 26, 2015 | Substantially Equivalent | BSN MEDICAL GMBH |
| K143124 | KA01 Chitosan Wound Dressing | Jan 26, 2015 | Substantially Equivalent | FOSHAN UNITED MEDICAL TECHNOLOGIES LTD. |
| K133729 | WOUND DRESSING WITH MANUKA HONEY | Jan 23, 2015 | Substantially Equivalent | MANUKA HEALTH NEW ZEALAND LTD. |
| K143001 | SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING | Nov 07, 2014 | Substantially Equivalent | ARGENTUM MEDICAL |
| K140389 | CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4 | Nov 07, 2014 | Substantially Equivalent | ENTROTECH LIFE SCIENCES INC. |
| K141660 | NAWALUTION SKIN AND WOUND CLEANSER | Oct 31, 2014 | Substantially Equivalent | NAWA HEILMITTEL GMBH |
| K141603 | Ultra Silver Dressings | Oct 22, 2014 | Substantially Equivalent | MILLIKEN HEALTHCARE PRODUCTS, LLC |
| K141573 | SILVERLON ISLAND WOUND DRESSING | Aug 28, 2014 | Substantially Equivalent | ARGENTUM MEDICAL |
| K132326 | IONSIL GEL | Aug 21, 2014 | Substantially Equivalent | VIRCHOW BIOTECH PVT. LTD. |
| K141012 | HYDROCLEANSE WOUND CARE SOLUTION | Aug 08, 2014 | Substantially Equivalent | OCULUS INNOVATIVE SCIENCES |
| K132891 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER | Jun 19, 2014 | Substantially Equivalent | THE HYMED GROUP CORP. |
| K140483 | ASAP OTC WOUND DRESSING GEL | May 20, 2014 | Substantially Equivalent | ABL MEDICAL, LLC |
| K131176 | ROSS RU SKIN DISCONTINUITIES | May 12, 2014 | Substantially Equivalent | BIOTD, S.A. |
| K133934 | MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER) | May 02, 2014 | Substantially Equivalent | LINKS MEDICAL PRODUCTS, INC. |
| K122817 | SILVERLON ISLAND WOUND DRESSING | May 01, 2014 | Substantially Equivalent | ARGENTUM MEDICAL, LLC. |
| K133542 | PURACYN PLUS SKIN AND WOUND | Apr 28, 2014 | Substantially Equivalent | INNOVACYN, INC. |
| K140147 | BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE | Apr 22, 2014 | Substantially Equivalent | BIO-MEDICAL CARBON TECHNOLOGY CO., LTD. |
| K132105 | PERCLOT TOPICAL | Apr 03, 2014 | Substantially Equivalent | CRYOLIFE, INC. |
| K131848 | VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ) | Mar 31, 2014 | Substantially Equivalent | PURICORE INC. |
| K133775 | EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING | Mar 26, 2014 | Substantially Equivalent | EXCITON TECHNOLOGIES INC. |
| K131796 | MANUKA FILL WOUND DRESSING | Mar 14, 2014 | Substantially Equivalent | LINKS MEDICAL PRODUCTS, INC. |
| K133764 | CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL | Mar 13, 2014 | Substantially Equivalent | AVERY DENNISON BELGIE, BVBA |
| K123193 | IPM WOUND GEL BIO | Mar 03, 2014 | Substantially Equivalent | GLYCOBIOSCIENCES, INC |
| K130781 | L.A.M. IPM WOUND GEL, IPM DERM GEL | Feb 14, 2014 | Substantially Equivalent | GLYCOBIOSCIENCES, INC |
| K130040 | MEPITEL AG | Feb 12, 2014 | Substantially Equivalent | MOLNLYCKE HEALTH CARE |
| K130670 | HYDROFERA BLUE PU BACTERIOSTATIC DRESSING | Jan 02, 2014 | Substantially Equivalent | HYDROFERA, LLC. |
| K132329 | NIVATOPIC PLUS | Dec 20, 2013 | Substantially Equivalent | NIVAGEN PHARMACEUTICALS INC. |
| K123678 | HYALMIX CREAM | Dec 16, 2013 | Substantially Equivalent | IGI LABORATORIES, INC. |
| K123910 | WOUNDWASH SALINE SPRAY | Oct 29, 2013 | Substantially Equivalent | NEILMED PHARMACEUTICALS, INC. |
| K130857 | PRONTOSAN WOUND GEL X | Oct 08, 2013 | Substantially Equivalent | B. BRAUN MEDICAL, INC. |
| K123724 | DERMISEB CREAM | Aug 28, 2013 | Substantially Equivalent | IGI LABORATORIES, INC. |
| K123904 | PROTHELIAL | Aug 07, 2013 | Substantially Equivalent | MUELLER MEDICAL INTERNATIONAL LLC |
| K131542 | NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC | Jul 24, 2013 | Substantially Equivalent | Novabay Pharmaceuticals, Inc |
| K130553 | ABSOCLEAR | Jul 03, 2013 | Substantially Equivalent | PHARMAPLAST S.A.E. |
| K130350 | PROCELLERA | Jul 02, 2013 | Substantially Equivalent | VOMARIS INNOVATIONS INC. |
| K123481 | AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE | Jun 06, 2013 | Substantially Equivalent | CONVATEC INC |
| K123394 | CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING | Jun 06, 2013 | Substantially Equivalent | CORELEADER BIOTECH CO., LTD. |
| K122595 | HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM | May 01, 2013 | Substantially Equivalent | DERMAL LIFE LLC |
| K123961 | SENTREX BIOSPONGE MPD | Apr 05, 2013 | Substantially Equivalent | BIONOVA MEDICAL, INC |
| K123892 | MEPILEX TRANSFER AG | Apr 05, 2013 | Substantially Equivalent | MOLNLYCKE HEALTH CARE |
| K123219 | URGOCLEAN ABSORBENT WOUND DRESSING | Mar 18, 2013 | Substantially Equivalent | LABORATOIRES URGO |
| K122634 | IODOFOAM IODOPHOR FOAM DRESSING | Mar 12, 2013 | Substantially Equivalent | PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC |
| K123679 | 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING | Feb 28, 2013 | Substantially Equivalent | 3M COMPANY |
| K123072 | VASHE WOUND THERAPY SOLUTION | Feb 14, 2013 | Substantially Equivalent | PURICORE, INC. |
| K120181 | LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM | Feb 14, 2013 | Substantially Equivalent | HUIZHOU FORYOU MEDICAL DEVICES CO, LTD |
| K123071 | VASHE SKIN AND WOUND HYDROGEL | Jan 24, 2013 | Substantially Equivalent | PURICORE, INC. |
| K123113 | L.A.M. IMP WOUND GEL | Dec 11, 2012 | Substantially Equivalent | GLYCOBIOSCIENCES, INC |
| K113693 | NIXALL TM WOUND AND SKIN CARE | Dec 11, 2012 | Substantially Equivalent | SERIOUSLY CLEAN LTD |
| K121559 | HYLATOPICPLUS LOTION | Nov 30, 2012 | Substantially Equivalent | PRECISION DERMATOLOGY INCORPORATED |
| K121361 | CURALINE POLYURETHANE FOAM AWC DRESSING | Nov 30, 2012 | Substantially Equivalent | CURALINE INC |
| K120930 | CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING | Oct 26, 2012 | Substantially Equivalent | MEDTRADE PRODUCTS LTD. |
| K113836 | BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) | Sep 24, 2012 | Substantially Equivalent | AVERY DENNISON BELGIE, BVBA |
| K120730 | LOUTREX TOPICAL CREAM | Sep 06, 2012 | Substantially Equivalent | ACELLA PHARMACEUTICALS, LLC |
| K122297 | ENLUXTRA HUMIFIBER WOUND DRESSING | Aug 28, 2012 | Substantially Equivalent | BASF VENTURE CAPITAL AMERICA INC. |
| K121819 | SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER | Aug 13, 2012 | Substantially Equivalent | COVALON TECHNOLOGIES, INC. |
| K113820 | NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER | Aug 08, 2012 | Substantially Equivalent | NOVABAY PHARMACEUTICALS |
| K121275 | AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER | Jul 25, 2012 | Substantially Equivalent | CONVATEC INC |
| K121134 | TL TRISEB CREAM | Jul 25, 2012 | Substantially Equivalent | TRIGEN LABORATORIES, INC. |
| K121407 | OXYBAND WOUND DRESSING | Jul 09, 2012 | Substantially Equivalent | O2S, LLC |
| K121522 | POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) | Jun 27, 2012 | Substantially Equivalent | POLYREMEDY, INC. |
| K112191 | HEALEX BIOSPONGE WOUND DRESSING | Jun 05, 2012 | Substantially Equivalent | BIONOVA MEDICAL, INC |
| K111382 | CELVER | May 31, 2012 | Substantially Equivalent | CELLULOSE CONCEPTS LLC |
| K121227 | MANUKA FILL | May 23, 2012 | Substantially Equivalent | LINKS MEDICAL PRODUCTS, INC. |
| K120976 | MANUKA IG | May 23, 2012 | Substantially Equivalent | LINKS MEDICAL PRODUCTS, INC. |
| K112549 | IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER | May 04, 2012 | Substantially Equivalent | COVALON TECHNOLOGIES, INC. |
| K112666 | SALINE WOUND WASH | Apr 20, 2012 | Substantially Equivalent | NANOPLAS, INC. |
| K113583 | CURAD ANTIBACTERIAL BANDAGE | Apr 12, 2012 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K120828 | BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES | Apr 05, 2012 | Substantially Equivalent | COLOPLAST A/S |
| K113807 | DEXERYL CREAM | Mar 07, 2012 | Substantially Equivalent | PIERRE FABRE MEDICAL DEVICES |
| K113774 | HPR PLUS EMOLLIENT FOAM | Feb 09, 2012 | Substantially Equivalent | PRUGEN IP HOLDINGS, INC |
| K113772 | HPR EMOLLIENT FOAM | Feb 09, 2012 | Substantially Equivalent | PRUGEN IP HOLDINGS, INC |
| K113564 | EXSALT T7 WOUND DRESSING | Dec 15, 2011 | Substantially Equivalent | EXCITON TECHNOLOGIES INC. |
| K111168 | PRECISION SKIN EMULSION | Dec 13, 2011 | Substantially Equivalent | PRECISION DERMATOLOGY INCORPORATED |
| K110457 | 3M TEGADERM MATRIX DRESSING | Dec 07, 2011 | Substantially Equivalent | 3M COMPANY |
| K110762 | AVO BARRIER TOPICAL EMULSION | Nov 18, 2011 | Substantially Equivalent | TRIGEN LABORATORIES, INC. |
| K111578 | CORELEADER COLLA-ALGI FIBER MODEL CAW | Sep 23, 2011 | Substantially Equivalent | CORELEADER BIOTECH CO., LTD. |
| K110062 | MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG | Sep 01, 2011 | Substantially Equivalent | MEDIPURPOSE PTE. LTD. |
| K110757 | TL-CERMIDE SKIN BARRIER EMULSION | Aug 19, 2011 | Substantially Equivalent | TRIGEN LABORATORIES, INC. |
| K110172 | SONAFINE WOUND DRESSING | Aug 19, 2011 | Substantially Equivalent | STRATUS PHARMACEUTICAL |
| K110546 | MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY | Jul 27, 2011 | Substantially Equivalent | DERMA SCIENCES, INC. |
| K101114 | ADVANCIS ACTIVON TUBE | Jul 26, 2011 | Substantially Equivalent | Advancis Medical |
| K102942 | CORELEADER ALGIPLASTER MODEL AP 050501 | Jun 22, 2011 | Substantially Equivalent | CORELEADER BIOTECH CO., LTD. |
| K103713 | ELTA WOUND CLEANSER | Jun 16, 2011 | Substantially Equivalent | SWISS AMERICAN PRODUCTS, INC. |
| K110732 | EMULSION SB | Jun 03, 2011 | Substantially Equivalent | PRUGEN IP HOLDINGS, INC |
| K103067 | EXSALT SD7 WOUND DRESSING | May 20, 2011 | Substantially Equivalent | EXCITON TECHNOLOGIES INC. |
| K103793 | DURAFIBER AG | May 02, 2011 | Substantially Equivalent | Smith & Nephew, Inc |
| K102943 | CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 | Apr 12, 2011 | Substantially Equivalent | CORELEADER BIOTECH CO., LTD. |
| K110744 | PRONTOSAN WOUND IRRIGATION SOLUTION | Apr 06, 2011 | Substantially Equivalent | B. BRAUN MEDICAL, INC. |
| K110727 | HYLATOPICPLUS CREAM | Apr 01, 2011 | Substantially Equivalent | PRECISION DERMATOLOGY INCORPORATED |
| K103106 | CHLORASHIELD TM ANTIMICROBIAL DRESSING | Mar 30, 2011 | Substantially Equivalent | CARE FUSION 213 LLC |
| K110042 | MANUKATEX | Mar 24, 2011 | Substantially Equivalent | MANUKA MEDICAL LIMITED |
| K110458 | SILVER ANTIMICROBIAL WOUND GEL | Mar 14, 2011 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS LIMITED |
| K101793 | MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY | Feb 22, 2011 | Substantially Equivalent | DERMA SCIENCES, INC. |
| K102945 | PEDIACYN ATOPIC DERMATITIS HYDROGEL | Feb 02, 2011 | Substantially Equivalent | OCULUS INNOVATIVE SCIENCES, INC. |
| K100948 | HYPO CLENZ WOUND WASH MODEL 100 PPM | Feb 02, 2011 | Substantially Equivalent | NEVOA LIFE SCIENCES, LLC |
| K100591 | SORBACT | Jan 24, 2011 | Substantially Equivalent | ABIGO MEDICAL AB |
| K103141 | LOW ADHERENT AFM AG DRESSINGS | Jan 21, 2011 | Substantially Equivalent | MILLIKEN HEALTHCARE PRODUCTS, LLC |
| K100613 | BIOMED WOUND CLEANSER | Jan 05, 2011 | Substantially Equivalent | BIOMED LABORATORIES, INC |
| K101118 | ACTIVON TULLE | Dec 15, 2010 | Substantially Equivalent | CALIDAD SOLUTIONS, INC. |
| K100261 | PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD | Dec 10, 2010 | Substantially Equivalent | TEI BIOSCIENCES INC. |
| K102659 | MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER | Dec 08, 2010 | Substantially Equivalent | MANUKA MEDICAL LIMITED |
| K102478 | OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING | Nov 03, 2010 | Substantially Equivalent | SOUTHWEST TECHNOLOGIES, INC. |
| K101882 | PRONTOSAN ANTIMICROBIAL WOUND GEL | Nov 03, 2010 | Substantially Equivalent | B. BRAUN MEDICAL, INC. |
| K100580 | EXSALT WOUND DRESSING | Oct 12, 2010 | Substantially Equivalent | EXCITON TECHNOLOGIES INC. |
| K100029 | MEPILEX BORDER AG DRESSING | Sep 15, 2010 | Substantially Equivalent | MOLNLYCKE HEALTH CARE |
| K100693 | AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING | Aug 10, 2010 | Substantially Equivalent | MEDTRADE PRODUCTS LIMITED |
| K100918 | VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 | Aug 09, 2010 | Substantially Equivalent | PURICORE INC. |
| K102002 | TALYMED | Jul 28, 2010 | Substantially Equivalent | MARINE POLYMER TECHNOLOGIES |
| K093159 | PR CREAM | Jun 24, 2010 | Substantially Equivalent | PRUGEN IP HOLDINGS, INC |
| K093156 | PRUCLAIR NONSTEROIDAL CREAM | Jun 24, 2010 | Substantially Equivalent | PRUGEN IP HOLDINGS, INC |
| K093320 | DRYODINE CADEXOMER-IODINE GEL | Jun 18, 2010 | Substantially Equivalent | COLLEGIUM PHARMACEUTICAL INCORPORATED |
| K093351 | COLLAWOUND ART | Jun 16, 2010 | Substantially Equivalent | COLLAMATRIX, INC |
| K100430 | URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER | Jun 11, 2010 | Substantially Equivalent | LABORATOIRES URGO |
| K100429 | URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER | Jun 11, 2010 | Substantially Equivalent | LABORATOIRES URGO |
| K092689 | MANUKAPLI WOUND DRESSING | May 20, 2010 | Substantially Equivalent | MANUKA MEDICAL LIMITED |
| K100839 | BARIREP | May 11, 2010 | Substantially Equivalent | GORBEC PHARMACEUTICAL SERVICES, INC. |
| K093697 | VASHE WOUND THERAPY SOLUTION | Apr 13, 2010 | Substantially Equivalent | PURICORE INC. |
| K092351 | POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS | Apr 08, 2010 | Substantially Equivalent | POLYREMEDY, INC. |
| K092348 | POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS | Apr 08, 2010 | Substantially Equivalent | POLYREMEDY, INC. |
| K093585 | MICROCYN SKIN AND WOUND HYDROGEL | Mar 08, 2010 | Substantially Equivalent | OCULUS INNOVATIVE SCIENCES, INC. |
| K093155 | VASHE WOUND CLEANSING SYSTEM | Mar 01, 2010 | Substantially Equivalent | PURICORE INC. |
| K100218 | BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM | Feb 17, 2010 | Substantially Equivalent | COLOPLAST A/S |
| K093188 | AFM ULTRA AG DRESSINGS | Feb 17, 2010 | Substantially Equivalent | MILLIKEN & CO. |
| K093544 | TROPAZONE CR | Feb 16, 2010 | Substantially Equivalent | MIDLOTHIAN LABORATORIES |
| K092257 | JALOSKIN | Jan 26, 2010 | Substantially Equivalent | FIDIA ADVANCED BIOPOLYMERS SRL |
| K091863 | AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS | Jan 21, 2010 | Substantially Equivalent | AUBREY, INC. |
| K092878 | PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE | Jan 15, 2010 | Substantially Equivalent | PRUGEN IP HOLDINGS, INC |
| K093349 | MEDLINE CURAD WOUND DRESSINGS | Jan 07, 2010 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K090345 | MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL | Jan 07, 2010 | Substantially Equivalent | CONSEAL INTERNATIONAL, INC. |
| K091034 | AQUACEL AG SURGICAL | Dec 16, 2009 | Substantially Equivalent | CONVATEC |
| K093227 | SILVERSTREAM AND DERMASEPT | Dec 10, 2009 | Substantially Equivalent | ENZYSURGE, LTD. |
| K093051 | HYLATOPIC PLUS EMOLLIENT FOAM | Dec 07, 2009 | Substantially Equivalent | COLLEGIUM PHARMACEUTICAL INCORPORATED |
| K092826 | ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL | Nov 12, 2009 | Substantially Equivalent | AMERICAN BIOTECH LABS |
| K083133 | SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS | Oct 30, 2009 | Substantially Equivalent | ANDOVER HEALTHCARE INC. |
| K090823 | THERAFORM BILAYER | Oct 22, 2009 | Substantially Equivalent | SEWON CELLONTECH CO., LTD. |
| K091354 | ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING | Oct 21, 2009 | Substantially Equivalent | ACRYMED, INC. |
| K092297 | ELETONE CREAM | Oct 09, 2009 | Substantially Equivalent | FERNDALE PHARMA GROUP, INC. |
| K090254 | SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) | Sep 04, 2009 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. |
| K092232 | MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 | Aug 19, 2009 | Substantially Equivalent | PURICORE INC. |
| K090337 | TROPAZONE LOTION | Aug 13, 2009 | Substantially Equivalent | MIDLOTHIAN LABORATORIES |
| K081246 | TT-102 | Aug 13, 2009 | Substantially Equivalent | TISSUE TECHNOLOGIES HOLDINGS, LLC |
| K090791 | DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% | Aug 07, 2009 | Substantially Equivalent | CENTURY PHARMACEUTICALS, INC. |
| K092086 | AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 | Jul 30, 2009 | Substantially Equivalent | AMERX HEALTH CARE CORP. |
| K091719 | NEOSALUS LOTION | Jul 30, 2009 | Substantially Equivalent | QUINNOVA PHARMACEUTICALS |
| K091013 | SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND | Jul 30, 2009 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS LIMITED |
| K083870 | EXSALT SD7 WOUND DRESSING | Jul 30, 2009 | Substantially Equivalent | EXCITON TECHNOLOGIES INC. |
| K083334 | ELASTO-GEL MANUKA HONEY WOUND DRESSING | Jul 30, 2009 | Substantially Equivalent | SOUTHWEST TECHNOLOGIES, INC. |
| K083113 | ACTICOAT FLEX 7 DRESSING | Jul 22, 2009 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K090894 | COLLAWOUND WOUND DRESSING | Jun 25, 2009 | Substantially Equivalent | COLLAMATRIX CO., INC. |
| K082910 | CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES | Jun 17, 2009 | Substantially Equivalent | ASO LLC |
| K090206 | OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER | Jun 02, 2009 | Substantially Equivalent | OCULUS INNOVATIVE SCIENCES, INC. |
| K090725 | OCULUS MICROCYN WOUND GEL | May 20, 2009 | Substantially Equivalent | OCULUS INNOVATIVE SCIENCES, INC. |
| K090092 | SOCKIT! AND MCMERLIN DERMAL WOUND GEL | May 11, 2009 | Substantially Equivalent | MCMERLIN DENTAL PRODUCTS LP |
| K083659 | SILVER WOUND PAD | Apr 16, 2009 | Substantially Equivalent | MILLIKEN & CO. |
| K083007 | PROWICK | Apr 08, 2009 | Substantially Equivalent | ARTHREX, INC. |
| K090585 | NEOSALUS CREAM | Apr 02, 2009 | Substantially Equivalent | QUINNOVA PHARMACEUTICALS |
| K082333 | ASAP WOUND DRESSING GEL | Apr 02, 2009 | Substantially Equivalent | AMERICAN BIOTECH LABS |
| K090141 | PRONTOSAN ANTIMICROBIAL WOUND GEL | Mar 17, 2009 | Substantially Equivalent | B. BRAUN MEDICAL, INC. |
| K090453 | SILVER ALGINATE 11 WOUND DRESSING | Feb 26, 2009 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS LIMITED |
| K083103 | ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B | Feb 26, 2009 | Substantially Equivalent | ACRYMED, INC. |
| K082296 | COPA AMD | Feb 26, 2009 | Substantially Equivalent | COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR |
| K080949 | KERATEC WOUND DRESSINGS | Feb 11, 2009 | Substantially Equivalent | KERATEC LIMITED |
| K082089 | PRUMYX CREAM | Jan 13, 2009 | Substantially Equivalent | PRUGEN, INC. |
| K083355 | WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 | Dec 29, 2008 | Substantially Equivalent | BLAIREX LABORATORIES, INC. |
| K083042 | WOUND FLUSH, STERILE WATER & NORMAL SALINE | Dec 18, 2008 | Substantially Equivalent | NURSE ASSIST, INC. |
| K081977 | PROSIT WOUND TREATMENT DEVICE | Dec 01, 2008 | Substantially Equivalent | SILVERLEAF MEDICAL PRODUCTS, INC. |
| K080503 | SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING | Nov 12, 2008 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS LIMITED |
| K082856 | CARAPASTE ORAL WOUND DRESSING | Oct 15, 2008 | Substantially Equivalent | MCGRATH PHARMACEUTICALS, INC. |
| K082330 | PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION | Oct 09, 2008 | Substantially Equivalent | PRIMARY CARE SOLUTIONS, INC. |
| K081363 | NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING | Sep 24, 2008 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS LIMITED |
| K082459 | ACRYDERM ABSORBENT OXYGEN DRESSING | Sep 19, 2008 | Substantially Equivalent | ACRYMED, INC. |
| K073019 | SILVERMED ANTIMICROBIAL SILVER HYDROGEL | Sep 16, 2008 | Substantially Equivalent | ARGENTIS BIOMEDICAL INCORPORATED |
| K070309 | NEOSALUS | Sep 12, 2008 | Substantially Equivalent | QUINNOVA PHARMACEUTICALS |
| K073197 | SILVER ANTIMICROBIAL WOUND GEL | Aug 28, 2008 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS LIMITED |
| K080497 | DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG) | Jun 27, 2008 | Substantially Equivalent | DERMA SCIENCES CANADA, INC. |
| K081584 | DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY | Jun 19, 2008 | Substantially Equivalent | DERMA SCIENCES, INC. |
| K072876 | PRONTOSAN WOUND IRRIGATION SOLUTION | Jun 19, 2008 | Substantially Equivalent | B. BRAUN MEDICAL, INC. |
| K081274 | SURESKIN SILVER BANDAGES | May 28, 2008 | Substantially Equivalent | EUROMED, INC. |
| K073213 | THERABOND ANTIMICROBIAL BARRIER SYSTEMS | May 28, 2008 | Substantially Equivalent | CHOICE THERAPEUTICS |
| K080620 | MODIFICATION TO 3M TEGADERM CHG DRESSING | May 19, 2008 | Substantially Equivalent | 3M COMPANY-3M HEALTH CARE |
| K070463 | REVERA WOUND CARE, MODEL MDW0060 | May 07, 2008 | Substantially Equivalent | REVALESIO CORPORATION |
| K080383 | AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING | May 02, 2008 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. |
| K071442 | SUPRASORB A +AG | May 01, 2008 | Substantially Equivalent | SPECIALTY FIBRES AND MATERIALS LTD. |
| K071552 | PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING | Apr 25, 2008 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K080524 | CENTURION SORBAVIEW OTC | Apr 23, 2008 | Substantially Equivalent | TRI-STATE HOSPITAL SUPPLY CORP. |
| K080315 | DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY | Apr 23, 2008 | Substantially Equivalent | DERMA SCIENCES, INC. |
| K073610 | ELTA ADVANCED WOUND WASH | Apr 23, 2008 | Substantially Equivalent | SWISS AMERICAN PRODUCTS, INC. |
| K073547 | ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL | Apr 23, 2008 | Substantially Equivalent | ANACAPA TECHNOLOGIES, INC. |
| K071483 | TETRIX CREAM | Apr 04, 2008 | Substantially Equivalent | CORIA LABORATORIES, LTD |
| K080010 | NOCC HYDROPHILIC WOUND DRESSING | Mar 14, 2008 | Substantially Equivalent | KYTOGENICS, INC |
| K080471 | RADIO BIOAQUACARE | Mar 05, 2008 | Substantially Equivalent | BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC |
| K071557 | COLLAWOUND HYDROGEL | Feb 08, 2008 | Substantially Equivalent | COLLAMATRIX CO., INC. |
| K072068 | BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS | Dec 21, 2007 | Substantially Equivalent | BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC |
| K073251 | HYALOMATRIX PA | Dec 14, 2007 | Substantially Equivalent | FIDIA ADVANCED BIOPOLYMERS SRL |
| K071371 | COPA AMD ANTIMICROBIAL WOUND DRESSING | Nov 19, 2007 | Substantially Equivalent | TYCO HEALTHCARE GROUP, LP |
| K072378 | PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 | Nov 09, 2007 | Substantially Equivalent | ARTHREX, INC. |
| K072956 | MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY | Nov 07, 2007 | Substantially Equivalent | DERMA SCIENCES, INC. |
| K071056 | NEUTROPHASE WOUND CLEANSER | Sep 28, 2007 | Substantially Equivalent | NOVABAY PHARMACEUTICALS |
| K070685 | KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 | Sep 14, 2007 | Substantially Equivalent | TYCO HEALTHCARE |
| K070653 | KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 | Sep 12, 2007 | Substantially Equivalent | TYCO HEALTHCARE |
| K071703 | ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC | Aug 22, 2007 | Substantially Equivalent | SWISS AMERICAN PRODUCTS, INC. |
| K063835 | ALLEVYN AG DRESSING | Aug 03, 2007 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K053613 | L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE | Jul 25, 2007 | Substantially Equivalent | THEO MANUFACTURING BV |
| K071354 | MEPILEX AG DRESSING | Jul 13, 2007 | Substantially Equivalent | MONLYCKE HEALTH CARE |
| K070581 | SILVER ALGINATE II WOUND DRESSING | Jul 13, 2007 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS LIMITED |
| K063805 | SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901 | Jul 13, 2007 | Substantially Equivalent | NUCRYST PHARMACEUTICALS, INC. |
| K063069 | SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION | Jul 13, 2007 | Substantially Equivalent | MEDICAL MOLECULAR THERAPUETICS LLC |
| K053095 | HONEY ALGINATE DRESSING | Jul 12, 2007 | Substantially Equivalent | DERMA SCIENCES CANADA, INC. |
| K070333 | ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL | Jul 10, 2007 | Substantially Equivalent | ACRYMED, INC. |
| K063063 | SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION | Jul 03, 2007 | Substantially Equivalent | MEDICAL MOLECULAR THERAPUETICS LLC |
| K070557 | MP 719 | May 23, 2007 | Substantially Equivalent | MARINE POLYMER TECHNOLOGIES, INC. |
| K063059 | SORBACT WOUND DRESSING | Apr 19, 2007 | Substantially Equivalent | ABIGO MEDICAL AB |
| K063271 | AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING | Apr 16, 2007 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, LLC. |
| K063458 | 3M TEGADERM CHG DRESSING | Apr 05, 2007 | Substantially Equivalent | 3M COMPANY |
| K984205 | SILVERLON ADHESIVE STRIP | Mar 19, 2007 | Substantially Equivalent | ARGENTUM INTERNATIONAL LLC. |
| K984204 | SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP | Mar 19, 2007 | Substantially Equivalent | ARGENTUM INTERNATIONAL LLC. |
| K060832 | RETRO-TECH DRESSING | Mar 13, 2007 | Substantially Equivalent | RETRO-TECH, LLC |
| K063517 | HEALADEX-P | Feb 16, 2007 | Substantially Equivalent | HEALAGENICS, INC. |
| K061467 | EXSEPT WC WOUND CLEANSER | Feb 15, 2007 | Substantially Equivalent | ALCAVIS INTERNATIONAL, INC. |
| K062559 | URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER | Jan 29, 2007 | Substantially Equivalent | LABORATOIRES URGO |
| K061554 | MEPILEX AG ABSORBENT SILICONE-COATED DRESSING | Jan 25, 2007 | Substantially Equivalent | MOLNLYCKE HEALTH CARE |
| K060272 | LOCOBASE WOUND AND SKIN EMULSION | Jan 12, 2007 | Substantially Equivalent | FERNDALE LABORATORIES, INC. |
| K061227 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER | Dec 20, 2006 | Substantially Equivalent | THE HYMED GROUP CORP. |
| K062212 | SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S | Nov 21, 2006 | Substantially Equivalent | ANACAPA TECHNOLOGIES, INC. |
| K063173 | MODIFICATION TO SILVER ALGINATE II WOUND DRESSING | Nov 03, 2006 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS LIMITED |
| K050158 | SINCLAIR SEBORRHEA EMULSION | Oct 11, 2006 | Substantially Equivalent | SINCLAIR PHARMACEUTICALS, LTD. |
| K053538 | MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER | Oct 10, 2006 | Substantially Equivalent | CURAPHARM, INC. |
| K061232 | ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 | Oct 06, 2006 | Substantially Equivalent | ACRYMED, INC. |
| K053590 | SILVERLON CA (CALCIUM ALGINATE) | Oct 06, 2006 | Substantially Equivalent | ARGENTUM MEDICAL, LLC. |
| K052536 | ALGICELL AG | Sep 13, 2006 | Substantially Equivalent | DERMA SCIENCES CANADA, INC. |
| K050842 | AGCEL WOUND DRESSING,AGCEL BURN DRESSING | Aug 02, 2006 | Substantially Equivalent | MODERN MEDICAL EQUIPMENT MFG., LTD. |
| K061220 | URGOTUL AG | Jul 27, 2006 | Substantially Equivalent | LABORATOIRES URGO |
| K061060 | TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8 | Jul 03, 2006 | Substantially Equivalent | TISSUE TECHNOLOGIES HOLDINGS, LLC |
| K060901 | VASHE WOUND CLEANSING SYSTEM | Jun 29, 2006 | Substantially Equivalent | STERILOX TECHNOLOGIES, INC. |
| K053476 | ALLWOUND | Jun 26, 2006 | Substantially Equivalent | AT SQUARED, LLC |
| K060237 | CMB ANTIMICROBIAL DRESSING | Jun 15, 2006 | Substantially Equivalent | SILVERLEAF MEDICAL PRODUCTS, INC. |
| K050032 | EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS | May 17, 2006 | Substantially Equivalent | EUROMED, INC. |
| K060804 | COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING | Apr 18, 2006 | Substantially Equivalent | COVALON TECHNOLOGIES LTD. |
| K052643 | EPICERAM | Apr 11, 2006 | Substantially Equivalent | CERAGENIX CORPORATION |
| K051542 | TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING | Mar 17, 2006 | Substantially Equivalent | TRIOSYN CORP. |
| K060113 | DERMACYN WOUND CARE | Feb 22, 2006 | Substantially Equivalent | OCULUS INNOVATIVE SCIENCES, INC. |
| K050086 | BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING | Feb 17, 2006 | Substantially Equivalent | BRENNEN MEDICAL, INC. |
| K052696 | COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING | Feb 03, 2006 | Substantially Equivalent | COVALON TECHNOLOGIES LTD. |
| K043587 | SUCRALFATE AND CARAFATE PASTE KITS | Feb 03, 2006 | Substantially Equivalent | PATRICK D. MCGRATH PH.D |
| K053256 | 3M TEGADERM SILVER (AG) MESH | Dec 16, 2005 | Substantially Equivalent | 3M COMPANY |
| K050726 | SILVERSEAL SILVERAID WITH X-STATIC | Dec 05, 2005 | Substantially Equivalent | NOBLE FIBER TECHNOLOGIES, INC. |
| K051647 | FORTADERM ANTIMICROBIAL WOUND DRESSING | Nov 08, 2005 | Substantially Equivalent | ORGANOGENESIS, INC. |
| K052720 | MEDLINE IODOFORM PACKING STRIPS | Oct 20, 2005 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K042352 | BIODERM SCIENCES WOUND CREAM | Oct 17, 2005 | Substantially Equivalent | BIODERM SCIENCES, INC. |
| K051445 | MILLIKEN SILVER WOUND DRESSINGS | Aug 22, 2005 | Substantially Equivalent | MILLIKEN CHEMICAL |
| K042084 | BIODERM SCIENCES WOUND HEALING SPRAY | Jun 15, 2005 | Substantially Equivalent | BIODERM SCIENCES, INC. |
| K050649 | SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC | Jun 13, 2005 | Substantially Equivalent | NOBLE FIBER TECHNOLOGIES, INC. |
| K042164 | SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) | Jun 09, 2005 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K043296 | COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING | Jun 06, 2005 | Substantially Equivalent | COVALON TECHNOLOGIES, INC. |
| K042729 | DERMACYN WOUND IRRIGATION | May 17, 2005 | Substantially Equivalent | OCULUS INNOVATIVE SCIENCES, INC. |
| K041059 | EPI-MAX | May 17, 2005 | Substantially Equivalent | DERMAGENICS, INC. |
| K041161 | MICROCYN WOUND CARE DRESSING | May 03, 2005 | Substantially Equivalent | OCULUS INNOVATIVE SCIENCES, INC. |
| K050030 | ACTICOAT MOISTURE CONTROL DRESSING | Apr 21, 2005 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K043063 | OXYBAND WOUND DRESSING | Mar 24, 2005 | Substantially Equivalent | OXYBAND TECHNOLOGIES, INC. |
| K033900 | X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING | Jan 14, 2005 | Substantially Equivalent | NOBLE FIBER TECHNOLOGIES |
| K033732 | MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450 | Dec 01, 2004 | Substantially Equivalent | MEDTRADE PRODUCTS LTD. |
| K042400 | MUCOTROL CONCENTRATED ORAL GEL WAFER | Nov 24, 2004 | Substantially Equivalent | BELCHER PHARMACEUTICALS, INC. |
| K040890 | 3M TEGADERM SILVER | Nov 02, 2004 | Substantially Equivalent | 3M COMPANY |
| K040518 | SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING | Oct 27, 2004 | Substantially Equivalent | SELECT FABRICATORS, INC. |
| K033523 | COLLAGEN-ORC ANTIMICROBIAL MATRIX | Oct 21, 2004 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, LTD. |
| K033164 | ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM | Sep 07, 2004 | Substantially Equivalent | DR. LEN'S MEDICAL PRODUCTS LLC |
| K032742 | SILVER FOAM WOUND DRESSING | Aug 16, 2004 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS LTD. |
| K041316 | ANTIMICROBIAL ALGINATE DRESSING | Aug 05, 2004 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS LTD. |
| K033587 | SILVERSEAL | Aug 05, 2004 | Substantially Equivalent | NOBLE FIBER TECHNOLOGIES |
| K041013 | SUILE OINTMENT WOUND DRESSING | Jul 07, 2004 | Substantially Equivalent | HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. |
| K040683 | BIODERM SCIENCES WOUND DRESSING | Jun 04, 2004 | Substantially Equivalent | BIODERM SCIENCES, INC. |
| K032983 | SENSITIVE SKIN ANTIBACTERIAL BANDAGES | Jun 01, 2004 | Substantially Equivalent | SCIVOLUTION, INC. |
| K033869 | CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) | May 17, 2004 | Substantially Equivalent | COLOPLAST CORP. |
| K033453 | KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING | Apr 29, 2004 | Substantially Equivalent | TYCO HEALTHCARE |
| K032463 | CURAD SILVER BANDAGE | Feb 10, 2004 | Substantially Equivalent | BEIERSDORF AG |
| K032462 | CURAD SILVER ACTIVE GEL BANDAGE | Feb 10, 2004 | Substantially Equivalent | BEIERSDORF AG |
| K031307 | FERRIS POLYMEM SILVER WOUND DRESSING | Oct 22, 2003 | Substantially Equivalent | FERRIS MFG. CORP. |
| K022967 | SUILE WOUND DRESSING | Jul 08, 2003 | Substantially Equivalent | HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. |
| K024298 | ANTIMICROBIAL ALGINATE DRESSING | Jun 30, 2003 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS LTD. |
| K013936 | SILVERLEAF CONTACT WOUND DRESSING | Mar 18, 2003 | Substantially Equivalent | SILVERLEAF TECHNOLOGIES INC |
| K022483 | ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING | Feb 03, 2003 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, LTD. |
| K022416 | CONTREET FOAM ADHESIVE/NON-ADHESIVE | Feb 03, 2003 | Substantially Equivalent | COLOPLAST CORP. |
| K020318 | SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES | Feb 03, 2003 | Substantially Equivalent | SCIVOLUTIONS, INC |
| K023612 | SILVERLON CONTACT WOUND DRESSING | Jan 24, 2003 | Substantially Equivalent | ARGENTUM INTERNATIONAL LLC. |
| K023609 | SILVERLON ADHESIVE STRIP | Jan 17, 2003 | Substantially Equivalent | ARGENTUM INTERNATIONAL LLC. |
| K023138 | HYDROFERA BACTERIOSTATIC WOUND DRESSING | Jan 17, 2003 | Substantially Equivalent | HYDROFERA, LLC. |
| K011618 | CALGITROL AG SILVER ALGINATE WOUND DRESSING | Nov 15, 2002 | Substantially Equivalent | ADRI |
| K022670 | CARRAKLENZ AND ULTRAKLENZ | Oct 17, 2002 | Substantially Equivalent | CARRINGTON LABORATORIES, INC. |
| K012816 | DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 | Oct 17, 2002 | Substantially Equivalent | DYNAREX CORP. |
| K013814 | ABSORBENT ANTIMICROBIAL WOUND DRESSING | Jun 21, 2002 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K020041 | IALUSET HYDROCOLLOID | Mar 14, 2002 | Substantially Equivalent | INSTITUT BIOCHIMIQUE SA (IBSA) |
| K014129 | PROMOGRAN MATRIX WOUND DRESSING | Feb 14, 2002 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, LTD. |
| K013462 | HYDROFERA BACTERIOSTATIC WOUND DRESSING | Jan 11, 2002 | Substantially Equivalent | HYDROFERA, LLC. |
| K003229 | BIOPATCH ANTIMICROBIAL DRESSING | Oct 26, 2001 | Substantially Equivalent | INTEGRA LIFESCIENCES CORP. |
| K012116 | ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING | Sep 12, 2001 | Substantially Equivalent | ACRYMED, INC. |
| K011941 | EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 | Aug 22, 2001 | Substantially Equivalent | THE KENDALL COMPANY |
| K010951 | ISLAND WOUND DRESSING WITH MICROBAN | Jun 11, 2001 | Substantially Equivalent | ISLAND DRESSING, LLC. |
| K004028 | ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING | Mar 27, 2001 | Substantially Equivalent | MAERSK MEDICAL, LTD. |
| K010447 | MODIFICATION TO ACTICOAT FOAM DRESSING | Mar 15, 2001 | Substantially Equivalent | WESTAIM BIOMEDICAL, INC. |
| K002896 | ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING | Feb 21, 2001 | Substantially Equivalent | THE WESTAIM CORP. |
| K002466 | ACTICOAT COMPOSITE DRESSING | Feb 16, 2001 | Substantially Equivalent | WESTAIM BIOMEDICAL, INC. |
| K002909 | ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 | Oct 13, 2000 | Substantially Equivalent | ACRYMED, INC. |
| K001519 | ACTICOAT 7 DRESSING | Oct 06, 2000 | Substantially Equivalent | WESTAIM BIOMEDICAL, INC. |
| K001023 | FREEDOM, MODEL 4660 | Sep 22, 2000 | Substantially Equivalent | JOHNSON & JOHNSON CONSUMER COMPANIES, INC. |
| K002599 | MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 | Sep 21, 2000 | Substantially Equivalent | ACRYMED, INC. |
| K992221 | ACTICOAT PRIMARY ANTIMICROBIAL DRESSING | Jun 07, 2000 | Substantially Equivalent | WESTAIM BIOMEDICAL, INC. |
| K991818 | ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 | Apr 17, 2000 | Substantially Equivalent | ACRYMED, INC. |
| K000051 | ACTICOAT FOAM DRESSING | Apr 05, 2000 | Substantially Equivalent | WESTAIM BIOMEDICAL, INC. |
| K993969 | SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION | Dec 30, 1999 | Substantially Equivalent | WINCHESTER LABORATORIES LLC. |
| K992817 | ANTIBACTERIAL ADHESIVE BANDAGE | Nov 05, 1999 | Substantially Equivalent | WILLIAM FEINSTEIN & ASSOCIATES, INC. |
| K984210 | SILVERLON WOUND PACKING STRIPS | Sep 24, 1999 | Substantially Equivalent | ARGENTUM INTERNATIONAL LLC. |
| K990810 | ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING | Sep 17, 1999 | Substantially Equivalent | MAERSK MEDICAL, LTD. |
| K992363 | SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN | Aug 12, 1999 | Substantially Equivalent | EUROMED, INC. |
| K991287 | SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA | Jun 29, 1999 | Substantially Equivalent | ADVANCED MEDICAL SOLUTIONS GROUP PLC |
| K990891 | DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING | May 27, 1999 | Substantially Equivalent for Some Indications | DERMAPHYLYX, INC. |
| K990332 | DUMEX IODOFORM PACKING STRIP | Apr 14, 1999 | Substantially Equivalent for Some Indications | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
| K990861 | WOUND DRESSING/ABD PAD, MODEL #10810 | Apr 12, 1999 | Substantially Equivalent | HOSPITAL SPECIALTY CO. |
| K990086 | HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM | Mar 31, 1999 | Substantially Equivalent | INTEGRA LIFESCIENCES CORP. |
| K990042 | SILON DUAL-DRESS | Mar 19, 1999 | Substantially Equivalent | BIO MED SCIENCES, INC. |
| K984599 | MODIFICATION OF CUTINOVA FOAM DRESSING | Mar 01, 1999 | Substantially Equivalent | BEIERSDORF-JOBT, INC. |
| K984597 | MODIFICATION OF CUTINOVA CAVITY DRESSING | Mar 01, 1999 | Substantially Equivalent | BEIERSDORF-JOBT, INC. |
| K984595 | MODIFICATION OF CUTINOVA HYDRO DRESSING | Mar 01, 1999 | Substantially Equivalent | BEIERSDORF-JOBT, INC. |
| K984593 | MODIFICATION OF CUTINOVA THIN DRESSING | Mar 01, 1999 | Substantially Equivalent | BEIERSDORF-JOBT, INC. |
| K984208 | SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD | Feb 22, 1999 | Substantially Equivalent | ARGENTUM INTERNATIONAL LLC. |
| K982493 | COMPEED PSORIASIS DRESSING | Jan 28, 1999 | Substantially Equivalent | COLOPLAST CORP. |
| K983173 | BIATAIN FOAM ADHESIVE DRESSING | Dec 16, 1998 | Substantially Equivalent for Some Indications | COLOPLAST CORP. |
| K983163 | BIATAIN FOAM DRESSING | Dec 16, 1998 | Substantially Equivalent | COLOPLAST CORP. |
| K983249 | SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN | Nov 25, 1998 | Substantially Equivalent | EUROMED, INC. |
| K981299 | SILVERLON CONTACT WOUND DRESSING | Sep 25, 1998 | Substantially Equivalent | ARGENTUM INTERNATIONAL LLC. |
| K980777 | DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING | May 04, 1998 | Substantially Equivalent | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
| K972185 | 20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE | Mar 05, 1998 | Substantially Equivalent for Some Indications | STERIPAK, LTD. |
| K974348 | ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING | Feb 13, 1998 | Substantially Equivalent | LABORATOIRES URGO S.A. |
| K973807 | DUODERM HYDROACTIVE PASTE | Dec 23, 1997 | Substantially Equivalent for Some Indications | CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
| K973689 | DUODERM HYDROACTIVE DRESSING | Dec 23, 1997 | Substantially Equivalent for Some Indications | CONVATEC LTD. |
| K973688 | DUODERM CONTROL GEL FORMULA BORDER DRESSING | Dec 23, 1997 | Substantially Equivalent for Some Indications | CONVATEC LTD. |
| K973632 | DUODERM CGF CONTROL GEL FORMULA DRESSING | Dec 22, 1997 | Substantially Equivalent for Some Indications | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K973717 | COMBIDERM ACD | Dec 17, 1997 | Substantially Equivalent for Some Indications | CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
| K973716 | DUODERM EXTRA THIN CGF DRESSING | Dec 17, 1997 | Substantially Equivalent for Some Indications | CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
| K973511 | KENDALL CURITY PETROLATUM GAUZE | Dec 16, 1997 | Substantially Equivalent for Some Indications | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
| K973507 | KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) | Dec 15, 1997 | Substantially Equivalent for Some Indications | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
| K973855 | IT HYDROCOLLOID WITH ZINC | Dec 01, 1997 | Substantially Equivalent for Some Indications | INNOVATIVE TECHNOLOGIES LTD. |
| K970566 | ARGLAES FILM DRESSING | Jul 29, 1997 | Substantially Equivalent for Some Indications | MAERSK MEDICAL, LTD. |
| K971126 | HYDROCOLLOID WOUND DRESSINGS | Jun 24, 1997 | Substantially Equivalent | INNOVATIVE TECHNOLOGIES LTD. |
| K964701 | MITRAFLEX PIGMENTED WOUND DRESSING | Feb 07, 1997 | Substantially Equivalent | POLYMEDICA INDUSTRIES, INC. |
| K963039 | SURESKIN STANDARD, BORDER, AND THIN | Sep 23, 1996 | Substantially Equivalent for Some Indications | EUROMED A/S |
| K962590 | SIGNALDRESS | Sep 20, 1996 | Substantially Equivalent for Some Indications | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K960815 | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL | Apr 29, 1996 | Substantially Equivalent | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
| K955863 | ALLDRESS MULTI LAYERED WOUND DRESSING | Mar 13, 1996 | Substantially Equivalent for Some Indications | MOLNLYCKE/SCOTT HEALTH CARE |
| K954243 | TECNOL SALINE WET DRESSING | Nov 29, 1995 | Substantially Equivalent | TECNOL MEDICAL PRODUCTS, INC. |
| K954743 | DERMAGRAN WOUND DRESSING CLEANER W/ZINC | Nov 02, 1995 | Substantially Equivalent | DERMA SCIENCES, INC. |
| K954742 | DERMAGRAN WET DRESSING (ZINC-SALINE) | Nov 02, 1995 | Substantially Equivalent | DERMA SCIENCES, INC. |
| K954740 | DERMAGRAN WOUND DRESSING | Nov 02, 1995 | Substantially Equivalent | DERMA SCIENCES, INC. |
| K954739 | DERMAGRAN HYDROPHILIC OINTMENT | Nov 02, 1995 | Substantially Equivalent | DERMA SCIENCES, INC. |
| K954621 | RECLOSABLE WOUND COVER | Oct 23, 1995 | Substantially Equivalent for Some Indications | HOLLISTER, INC. |
| K954235 | HOLLISTER HYDROCOLLOID WOUND DRESSING | Oct 06, 1995 | Substantially Equivalent | HOLLISTER, INC. |
| K952948 | SALINE DRESSING | Aug 16, 1995 | Substantially Equivalent for Some Indications | BUSSE HOSPITAL DISPOSABLES, INC. |
| K952907 | EX-111 WOUND DRESSING | Aug 07, 1995 | Substantially Equivalent | VARISEAL MANUFACTURING CORP. |
| K950933 | HOLLISTER HYDROCOLLOID WOUND DRESSINGS | Jul 11, 1995 | Substantially Equivalent | HOLLISTER, INC. |
| K952007 | ADHEROL SEPP APPLICATOR | Jun 08, 1995 | Substantially Equivalent | MEDI-FLEX HOSPITAL PRODUCTS, INC. |
| K950132 | DUMEX WET DRESSINGS | Mar 01, 1995 | Substantially Equivalent for Some Indications | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
| K942959 | KIT PAK WET SALINE DRESSING | Feb 14, 1995 | Substantially Equivalent for Some Indications | KIT PAK, INC. |
| K945675 | PREPPIES SKIN BARRIER WIPE | Feb 07, 1995 | Substantially Equivalent | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
| K931766 | STERIL-DERM-PLUS TRANSPARENT DRESSING | Jan 24, 1995 | Substantially Equivalent for Some Indications | BIOINTERFACE TECHNOLOGIES, INC. |
| K941688 | INNOVATIVE TECHNOLOGIES HYDROCOLLOID WOUND DRESSINGS | Sep 08, 1994 | Substantially Equivalent | INNOVATIVE TECHNOLOGIES LTD. |
| K941149 | DERMAASSIST HYDROCOLLOID DRESSING | May 20, 1994 | Substantially Equivalent for Some Indications | WILSHIRE MEDICAL PRODUCTS |
| K941005 | DERMASSIST(TM) XEROFORM PETROLATUM DRESSING | Apr 14, 1994 | Substantially Equivalent for Some Indications | WILSHIRE MEDICAL PRODUCTS |
| K940691 | WET DRESSING | Mar 31, 1994 | Substantially Equivalent for Some Indications | MEDTRAX INDUSTRIES, INC. |
| K936255 | CUSTOM CV PACK | Mar 31, 1994 | Substantially Equivalent for Some Indications | ASSOCIATED MEDICAL |
| K940694 | XEROFORM PETROLATUM DRESSING | Mar 30, 1994 | Substantially Equivalent for Some Indications | MEDTRAX INDUSTRIES, INC. |
| K940693 | PETROLATUM DRESSING | Mar 30, 1994 | Substantially Equivalent for Some Indications | MEDTRAX INDUSTRIES, INC. |
| K940110 | M-K WET SALINE DRESSING | Mar 22, 1994 | Substantially Equivalent for Some Indications | MASON-KELLER CORP. |
| K940076 | DERMASSIST WET DRESSING, WATER | Mar 03, 1994 | Substantially Equivalent | WILSHIRE MEDICAL PRODUCTS |
| K940044 | DERMASSIST WET DRESSING, SALINE | Mar 03, 1994 | Substantially Equivalent | WILSHIRE MEDICAL PRODUCTS |
| K936234 | DERMASSIST OIL EMULSION NON-ADHERING WOUND DRESSING | Mar 03, 1994 | Substantially Equivalent | WILSHIRE MEDICAL PRODUCTS |
| K936230 | DERMASSIST PETROLATUM GAUZE,USP | Mar 03, 1994 | Substantially Equivalent | WILSHIRE MEDICAL PRODUCTS |
| K940339 | IODOFORM PACKAGING STRIP | Feb 25, 1994 | Substantially Equivalent | ALBAHEALTH PRODUCTS |
| K932676 | SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER) | Dec 10, 1993 | Substantially Equivalent | POLYMEDICA INDUSTRIES, INC. |
| K934258 | SALINE WET DRESSING- STERILE | Nov 24, 1993 | Substantially Equivalent | TRINITY LABORATORIES, INC. |
| K933774 | IMC SALINE WET DRESSING | Nov 08, 1993 | Substantially Equivalent for Some Indications | INMAN MEDICAL CORP. |
| K933966 | SURE-ADAPT NON-ADHERING DRESSING | Oct 28, 1993 | Substantially Equivalent for Some Indications | MEDTRAX INDUSTRIES, INC. |
| K931510 | GERITREX STERILE SALINE WET DRESSING | Jul 13, 1993 | Substantially Equivalent | GERITREX CORP. |
| K930549 | LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000 | Jun 18, 1993 | Substantially Equivalent | RUSTRONICS, INC. |
| K924754 | DERMAGRAN WOUND DRESSING | May 27, 1993 | Substantially Equivalent | DERMA SCIENCES, INC. |
| K926207 | MEDTRAX PACKING STRIP | May 12, 1993 | Substantially Equivalent | MEDTRAX INDUSTRIES, INC. |
| K922729 | SPARTA WET DRESSING, SODIUM CHLORIDE | Nov 23, 1992 | Substantially Equivalent for Some Indications | SPARTA SURGICAL CORP. |
| K921290 | INMAN MEDICAL OIL EMULSION DRESSING | Nov 23, 1992 | Substantially Equivalent for Some Indications | INMAN MEDICAL CORP. |
| K921289 | INMAN MEDICAL PETROLATUM DRESSING | Nov 10, 1992 | Substantially Equivalent | INMAN MEDICAL CORP. |
| K920875 | PROLONGED OCCLUSION DRESSING I | Jun 16, 1992 | Substantially Equivalent | FERNDAL LABORATORIES |
| K920874 | PROLONGED OCCLUSION DRESSING II | Jun 16, 1992 | Substantially Equivalent | FERNDAL LABORATORIES |
| K915477 | STERILIZATION BAG, POLYESTER/WRAP | May 08, 1992 | Substantially Equivalent | CGS SUPPLIES CORP. |
| K914579 | SILVER FOAM WOUND DRESSING | Feb 21, 1992 | Substantially Equivalent | VITAPHORE CORP. |
| K914840 | DERMAPROOF | Jan 31, 1992 | Substantially Equivalent | PHARMALETT MEDICAL CARE, HOLLAND B.V. |
| K913035 | INCARE HOT/ICE ABSORBENT INTERFACE | Sep 25, 1991 | Substantially Equivalent | HOLLISTER, INC. |
| K913575 | GAUZE PACKING, SURGICAL STERILE AND NON-STERILE | Sep 06, 1991 | Substantially Equivalent | KEILEI INTL., INC. |
| K905040 | ALGINATE FIBER | Aug 21, 1991 | Substantially Equivalent for Some Indications | SHEPHERD MEDICAL CORP. |
| K905438 | NORMLGEL PROTECTIVE WOUND GEL | Apr 01, 1991 | Substantially Equivalent | SCOTT HEALTH CARE |
| K905519 | MONTROSE DRESSING APPLICATORS | Mar 06, 1991 | Substantially Equivalent | OLEMUNDA PTY LTD. |
| K905314 | ALGODERM ALGINATE WOUND DRESSING | Feb 19, 1991 | Substantially Equivalent | LES LABORATORIRES BROTHIER, S.A. |
| K901853 | MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS | Jan 28, 1991 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K904852 | DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK | Jan 25, 1991 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K901378 | TENSOPLUS LITE | Jun 12, 1990 | Substantially Equivalent | SMITH & NEPHEW UNITED, INC. |
| K902345 | CARRINGTON WOUND DRESSING | Jun 07, 1990 | Substantially Equivalent for Some Indications | CARRINGTON LABORATORIES, INC. |
| K901109 | WOUND TREATMENT KIT | Jun 06, 1990 | Unknown | ORION LIFE SYSTEMS, INC. |
| K901369 | GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II | Jun 05, 1990 | Substantially Equivalent | STERLING DRUG, INC. |
| K897142 | MESALT STERILE DRESSING | Mar 27, 1990 | Substantially Equivalent | SCOTT HEALTH CARE |
| K900516 | WATER JEL STERILE GEL-SOAKED BURN DRESSING | Mar 19, 1990 | Substantially Equivalent | TRILLING MEDICAL TECHNOLOGIES, INC. |
| K897156 | HYDRASORB(TM) | Feb 21, 1990 | Substantially Equivalent | AVITAR, INC. |
| K895654 | SORBEX(TM) SOFT SPONGE | Feb 20, 1990 | Substantially Equivalent for Some Indications | FOUNTAIN PHARMACEUTICALS, INC. |
| K896421 | TRANSPARENT FILM I.V. SITE/WOUND DRESSING | Jan 31, 1990 | Substantially Equivalent | CATALINA BIOMEDICAL CORP. |
| K896702 | WOUND DRESSING | Jan 19, 1990 | Substantially Equivalent | VIADERM PHARMACEUTICALS, INC. |
| K895817 | HERMAL WOUND CARE KIT | Jan 19, 1990 | Substantially Equivalent | STIEFEL RESEARCH INSTITUTE, INC. |
| K894226 | SILASTIC SOFT SHEETING | Jan 03, 1990 | Substantially Equivalent | DOW CORNING WRIGHT |
| K894541 | CARRINGTON DERMAL WOUND GEL | Nov 30, 1989 | Substantially Equivalent | CARRINGTON LABORATORIES, INC. |
| K896110 | BIOBRANE(R) II | Nov 28, 1989 | Substantially Equivalent | STERLING DRUG, INC. |
| K895845 | 2018 ARTERIAL/VENOUS PRESSURE DRESSING | Nov 01, 1989 | Substantially Equivalent | ADVANCE MEDICAL DESIGNS, INC. |
| K890107 | GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT | Oct 24, 1989 | Unknown | PREMIUM PLASTICS, INC. |
| K895207 | BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM | Sep 28, 1989 | Substantially Equivalent | JOHNSON & JOHNSON INTERNATIONAL |
| K894996 | EXUSORB(TM) GRANULES | Sep 28, 1989 | Substantially Equivalent | CONTROLLED THERAPEUTICS CORP. |
| K892851 | ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVER | Sep 26, 1989 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PATIENT CARE, INC. |
| K883619 | MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL | Sep 01, 1989 | Substantially Equivalent for Some Indications | MINNETONKA, INC. |
| K883566 | MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL | Sep 01, 1989 | Substantially Equivalent for Some Indications | MINNETONKA, INC. |
| K894254 | HYPAFIX DRESSING RETENTION SHEET | Aug 31, 1989 | Substantially Equivalent | SMITH & NEPHEW UNITED, INC. |
| K891097 | DAMOR CREAM SATURATED DRESSING | Aug 25, 1989 | Substantially Equivalent for Some Indications | DAMOR AMERICA, INC. |
| K894898 | 2ND SKIN NON-STICK MOIST BURN PADS | Aug 23, 1989 | Substantially Equivalent | SPENCO MEDICAL CORP. |
| K894347 | KALTOCARB WOUND DRESSING | Aug 23, 1989 | Substantially Equivalent | CALGON VESTAL DIV. |
| K891870 | INTRASITE* GEL (3) YEAR SHELF LIFE | Aug 09, 1989 | Substantially Equivalent | SMITH & NEPHEW UNITED, INC. |
| K892837 | STERIL-DERM TRANSPARENT WOUND DRESSING | Aug 01, 1989 | Substantially Equivalent | BIOINTERFACE TECHNOLOGIES, INC. |
| K885096 | PHYNE-VU | Jul 25, 1989 | Substantially Equivalent | MEDICAL RESOURCES, LTD. |
| K892868 | KALTOSTAT WOUND PACKING | Jul 14, 1989 | Substantially Equivalent | CALGON VESTAL DIV. |
| K892364 | KALTOSTAT(TM) WOUND DRESSING | Jun 23, 1989 | Substantially Equivalent | CALGON VESTAL DIV. |
| K885279 | CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS | Jun 13, 1989 | Substantially Equivalent | BEIERSDORF, INC. |
| K891288 | TEGASORB(TM) ULCER DRESSING, #90-XXX | Jun 09, 1989 | Substantially Equivalent for Some Indications | 3M COMPANY |
| K892360 | WATER JEL STERILE GEL-SOAKED BURN DRESSING | Jun 05, 1989 | Substantially Equivalent | PFIZER, INC. |
| K891998 | BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52 | Jun 05, 1989 | Substantially Equivalent | ELWYN INDUSTRIES |
| K891459 | STERILE BURNNET PRE-CUT (VARIOUS SIZES) | May 26, 1989 | Substantially Equivalent | WESTERN MEDICAL, LTD. |
| K891189 | WEDGE PRESSURE DRESSING | May 24, 1989 | Substantially Equivalent | DURDEN ENTERPRISES, INC. |
| K891133 | VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS | May 24, 1989 | Substantially Equivalent | ELWYN, INC. |
| K882558 | AREOLA/NIPPLE DRESSING | May 24, 1989 | Substantially Equivalent | COOPER SURGICAL/AESTHETE |
| K890603 | BEAM TECH WOUND DRESSING* | May 23, 1989 | Substantially Equivalent | BEAM TECH LTD. |
| K892527 | DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY | May 11, 1989 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K892232 | ACTIDERM*-OPAQUE | May 05, 1989 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K891696 | DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING | May 04, 1989 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K884791 | PERME-AID TRANSPARENT DRESSING, #11XX | May 04, 1989 | Substantially Equivalent | NITTO DENKO TECHNICAL CORP. |
| K890354 | TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X | Apr 27, 1989 | Substantially Equivalent for Some Indications | 3M COMPANY |
| K890940 | MODIFIED LABELING FOR POLYDERM WBC(TM) | Apr 17, 1989 | Substantially Equivalent | LAIVAN CORP. |
| K885325 | FRASTEC CONFORMANT DRESSING, VARIOUS SIZES | Apr 17, 1989 | Substantially Equivalent for Some Indications | FRASTEC WOUND CARE PRODUCTS, INC. |
| K890545 | NU-DERM HYDROCOLLOID DRESSING | Mar 23, 1989 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PATIENT CARE, INC. |
| K883391 | POLYMER ADHESIVE BANDAGE | Mar 23, 1989 | Substantially Equivalent for Some Indications | MARION LABORATORIES, INC. |
| K885321 | WATER JEL STERILE GEL-SOAKED BURN DRESSING | Mar 22, 1989 | Substantially Equivalent for Some Indications | PFIZER PHARMACEUTICALS |
| K890748 | ALLEVYN TRACHEOSTOMY DRESSING | Mar 08, 1989 | Substantially Equivalent for Some Indications | SMITH & NEPHEW UNITED, INC. |
| K885045 | PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH | Mar 03, 1989 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K884422 | POLYGLUCOSE POWDER | Feb 22, 1989 | Substantially Equivalent for Some Indications | ANTHONY N SILVETTI, M.D., S.C. |
| K883849 | REPLICARE (ADDITIONAL CLAIMS) | Feb 08, 1989 | Substantially Equivalent for Some Indications | UNITED MEDICAL |
| K884440 | TECNOL VARIABLE TENSION BANDAGE | Jan 17, 1989 | Substantially Equivalent for Some Indications | TECNOL NEW JERSEY WOUND CARE, INC. |
| K883224 | UNNA BOOT DRESSING W/CALAMINE | Jan 05, 1989 | Substantially Equivalent for Some Indications | GRAHAM-FIELD, INC. |
| K884397 | PHARMASEAL STERILE WOUND CARE DRESSING | Dec 27, 1988 | Substantially Equivalent for Some Indications | BAXTER HEALTHCARE CORP. |
| K881426 | PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE | Nov 10, 1988 | Substantially Equivalent for Some Indications | LABORATOIRE PAN-PRA |
| K882590 | VIADERM | Oct 07, 1988 | Substantially Equivalent for Some Indications | APPLIED BIOMEDICAL SCIENCES |
| K882567 | SKINCOTE | Oct 05, 1988 | Substantially Equivalent for Some Indications | DYNAREX CORP. |
| K883588 | COMPEED ATHLETIC DRESSING | Sep 22, 1988 | Substantially Equivalent for Some Indications | COLOPLAST A/S |
| K881936 | OPER-FILM-ADHESIVE MEMBRANE | Aug 31, 1988 | Substantially Equivalent for Some Indications | IBERHOSPITEX, S.A. |
| K881731 | AD-HEAL(TM) WOUND DRESSING | Aug 31, 1988 | Substantially Equivalent for Some Indications | NEPERA, INC. |
| K882696 | DERMICEL, MONTGOMERY STRAP | Aug 26, 1988 | Substantially Equivalent | BIOSEAL |
| K881854 | SORBSAN TOPICAL WOUND DRESSING | Jul 19, 1988 | Substantially Equivalent | E.G. DICK & ASSOC. |
| K881988 | 3M WOUND CONTACT MATERIAL, PRODUCT #563X | Jun 27, 1988 | Substantially Equivalent | 3M COMPANY |
| K881039 | HYDROCOLLOID DRESSING FOR PSORIASIS | Jun 22, 1988 | Substantially Equivalent | HOLLISTER, INC. |
| K881302 | DUODERM(R) HYDROACTIVE(R) PASTE | Apr 28, 1988 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K880153 | POLYDERM A+B(TM) | Apr 13, 1988 | Substantially Equivalent for Some Indications | LAIVAN CORP. |
| K875253 | BFGOODRICH BIOTHANE NON-ADHERENT DRESSING | Apr 13, 1988 | Substantially Equivalent for Some Indications | THE BFGOODRICH CO. |
| K881050 | DUODERM(R) CGF | Apr 01, 1988 | Substantially Equivalent for Some Indications | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K880788 | NON ADHERENT PAD | Apr 01, 1988 | Substantially Equivalent for Some Indications | CEDERROTH, INC. USA |
| K872298 | TEGASORB ULCER DRESSING #90-XXX | Apr 01, 1988 | Substantially Equivalent for Some Indications | 3M COMPANY |
| K880330 | FERRIS HYDROPHILIC DRESSING | Mar 23, 1988 | Substantially Equivalent for Some Indications | FERRIS MFG. CORP. |
| K881048 | AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA. | Mar 21, 1988 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K880206 | POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER | Mar 11, 1988 | Substantially Equivalent for Some Indications | LAIVAN CORP. |
| K874554 | ENVICLUSIVE (TM) | Mar 11, 1988 | Substantially Equivalent | MARION LABORATORIES, INC. |
| K872573 | PHARMACLUSIVE (TM) | Feb 29, 1988 | Substantially Equivalent | PHARMACIA, INC. |
| K880299 | REPLICARE | Feb 26, 1988 | Substantially Equivalent | UNITED MEDICAL |
| K874480 | MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) | Feb 22, 1988 | Substantially Equivalent for Some Indications | OMIKRON SCIENTIFIC, LTD. |
| K872926 | DERMATOLOGICAL PATCH | Feb 22, 1988 | Substantially Equivalent for Some Indications | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K864841 | WATER-JEL(R) BURN DRESSING | Jan 22, 1988 | Substantially Equivalent for Some Indications | TRILLING RESOURCES, LTD. |
| K874478 | DYNAFILM | Jan 14, 1988 | Substantially Equivalent for Some Indications | FERRIS MFG. CORP. |
| K874470 | MWI 400 WOUND DRESSING | Dec 18, 1987 | Substantially Equivalent for Some Indications | MED-WEST, INC. |
| K874161 | MODIFIED USE OF TRIANGLE BANDAGE STERILE | Dec 04, 1987 | Substantially Equivalent | K. W. GRIFFEN CO. |
| K874219 | S3 MEDICATED GAUZE | Nov 23, 1987 | Substantially Equivalent | SURGICAL SPECIALTIES, INC. |
| K873669 | COMFEEL ULCUS ULCER CARE SYSTEM | Nov 17, 1987 | Substantially Equivalent for Some Indications | COLOPLAST A/S |
| K874291 | EPI-LOCK T.M. PRIMADERM | Nov 10, 1987 | Substantially Equivalent for Some Indications | DERMA-LOCK MEDICAL CORP. |
| K871327 | D.R.P. THREE STEP WOUND DRESSING | Nov 09, 1987 | Substantially Equivalent for Some Indications | BIODERM, INC. |
| K873277 | MITRAFLEX(TM) WOUND DRESSING | Sep 17, 1987 | Substantially Equivalent for Some Indications | MATRIX MEDICA, INC. |
| K872988 | TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING | Sep 16, 1987 | Substantially Equivalent for Some Indications | SMITH & NEPHEW, INC. |
| K872875 | STRETCH GAUZE BANDAGES | Sep 04, 1987 | Substantially Equivalent | ABCO DEALERS, INC. |
| K872982 | JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING | Aug 14, 1987 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K871675 | FERRIS TRANSPARENT WOUND DRESSING W/HYDROCOLLOID | Aug 06, 1987 | Substantially Equivalent for Some Indications | FERRIS MFG. CORP. |
| K872624 | INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING | Jul 29, 1987 | Substantially Equivalent for Some Indications | SMITH & NEPHEW, INC. |
| K864913 | CUTINOVA(R) PLUS FOAM GELFILM | Jul 24, 1987 | Substantially Equivalent for Some Indications | BEIERSDORF, INC. |
| K872069 | KONTOUR ULTRA SOFT SPONGE #SS144.50 | Jul 14, 1987 | Substantially Equivalent for Some Indications | WINFIELD LABORATORIES, INC. |
| K871458 | SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW | Jul 09, 1987 | Substantially Equivalent | FRAASS SURVIVAL SYSTEMS, INC. |
| K872101 | BIOFILM TRANS. POUCH ULCER & WOUND DRESSING | Jun 30, 1987 | Substantially Equivalent for Some Indications | THE BFGOODRICH CO. |
| K872100 | BIOFILM TRANSORBENT ULCER AND WOUND DRESSING | Jun 30, 1987 | Substantially Equivalent for Some Indications | THE BFGOODRICH CO. |
| K872099 | BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS. | Jun 30, 1987 | Substantially Equivalent for Some Indications | THE BFGOODRICH CO. |
| K872165 | ELASTO-GEL OCCLUSIVE DRESSING | Jun 26, 1987 | Substantially Equivalent for Some Indications | SOUTHWEST TECHNOLOGIES, INC. |
| K871770 | AMERICAN PHARMASEAL WOUND DRESSING | Jun 26, 1987 | Substantially Equivalent for Some Indications | AMERICAN PHARMASEAL DIV. AHSC |
| K871166 | ALLEVYN HYDROPHILIC POLYURETHANE DRESSING | Jun 16, 1987 | Substantially Equivalent for Some Indications | SMITH & NEPHEW, INC. |
| K871255 | MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSING | May 29, 1987 | Substantially Equivalent for Some Indications | HERCON LABORATORIES CORP. |
| K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 | May 08, 1987 | Substantially Equivalent | I M, INC. |
| K870430 | PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG. | Apr 13, 1987 | Substantially Equivalent for Some Indications | STERIDYNE LABORATORIES, INC. |
| K870743 | HERCON ANTI. TRANS. DRESSING AS A WOUND DRESSING | Apr 06, 1987 | Substantially Equivalent for Some Indications | HERCON LABORATORIES CORP. |
| K870431 | GAUZE, ABSORBENT, IODOFORM IMPREGNATED | Feb 26, 1987 | Substantially Equivalent | STERIDYNE LABORATORIES, INC. |
| K870352 | RUBYCELL(TM) SYNTHETIC ISLAND DRESSING | Feb 26, 1987 | Substantially Equivalent for Some Indications | BIODERM, INC. |
| K870241 | COMPRESS AND BANDAGE, VARIOUS SIZES | Feb 06, 1987 | Substantially Equivalent | FRAASS SURVIVAL SYSTEMS, INC. |
| K870239 | DRESSING, BURN, 24 BY 36 INCHES | Feb 06, 1987 | Substantially Equivalent | FRAASS SURVIVAL SYSTEMS, INC. |
| K870185 | BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE) | Feb 06, 1987 | Substantially Equivalent | FRAASS SURVIVAL SYSTEMS, INC. |
| K870184 | BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES | Feb 06, 1987 | Substantially Equivalent | FRAASS SURVIVAL SYSTEMS, INC. |
| K865089 | FERRIS DYNADERM PLUS | Feb 04, 1987 | Substantially Equivalent for Some Indications | FERRIS MFG. CORP. |
| K864688 | ARNOLD-KING PRESSURE DRESSING | Jan 12, 1987 | Substantially Equivalent | ANGIOSYSTEMS, INC. |
| K863580 | DERMATEC TRANSPARENT FILM DRESSING | Dec 31, 1986 | Substantially Equivalent for Some Indications | DERMATEC, INC. |
| K863930 | VISCOPASTE ZINC PASTE BANDAGE | Dec 01, 1986 | Substantially Equivalent for Some Indications | SMITH & NEPHEW, INC. |
| K863578 | DERMATEC ZONE TRANSPARENT DRESSING | Nov 25, 1986 | Substantially Equivalent for Some Indications | DERMATEC, INC. |
| K864011 | EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES | Nov 22, 1986 | Substantially Equivalent for Some Indications | FRAASS SURVIVAL SYSTEMS, INC. |
| K864084 | LYOFOAM C ODOR-ABSORBING DRESSING | Nov 21, 1986 | Substantially Equivalent for Some Indications | ACME UNITED CORP. |
| K863389 | UNITED WOUND COVERING, PACKAGE OF 5 | Nov 17, 1986 | Substantially Equivalent for Some Indications | UNITED MEDICAL |
| K862803 | CHESEBROUGH POND'S HYDROCOLLOID DRESSING | Nov 14, 1986 | Substantially Equivalent for Some Indications | CHESEBROUGH-POND'S U.S.A. CO. |
| K863390 | HYDROCOLLOID DRESSINGS - STERILE | Sep 30, 1986 | Substantially Equivalent for Some Indications | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K863379 | DERMATEC BURN PADS | Sep 26, 1986 | Substantially Equivalent for Some Indications | DERMATEC, INC. |
| K862935 | WOUND MANAGER(TM) - STERILE | Aug 20, 1986 | Substantially Equivalent for Some Indications | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K862572 | HOLLISTER WOUND CARE BARRIER | Aug 04, 1986 | Substantially Equivalent for Some Indications | HOLLISTER, INC. |
| K860892 | CLINAGEL (ABSORBENT GEL) | Jul 23, 1986 | Substantially Equivalent for Some Indications | SCHERING CHEMICALS, C/O ELLIS PHARMACEUTICALS |
| K862163 | JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS | Jul 09, 1986 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K861384 | NON-ADHERING DRESSING WITH POVIDONE-IODINE | Jul 01, 1986 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K861972 | DERMISTRIP | Jun 27, 1986 | Substantially Equivalent for Some Indications | KELLS MEDICAL, INC. |
| K860085 | LYOFOAM WOUND DRESSINGS | Jun 27, 1986 | Substantially Equivalent for Some Indications | ACME UNITED CORP. |
| K861024 | BARD ABSORPTION DRESSING | Apr 10, 1986 | Substantially Equivalent for Some Indications | C.R. BARD, INC. |
| K860486 | ACTISORB ACTIVATED CHARCOAL DRESSING | Mar 26, 1986 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K854740 | PRIMADERM | Mar 14, 1986 | Substantially Equivalent for Some Indications | ABSORBENT COTTON CO., INC. |
| K854464 | IV SECUREMENT DEVICES | Mar 03, 1986 | Substantially Equivalent for Some Indications | AVERY INTL. |
| K854463 | ADHESIVE TAPE, WOUND CARE, WOUND DRESSING | Mar 03, 1986 | Substantially Equivalent for Some Indications | AVERY INTL. |
| K854850 | FALKON STRETCH-STERILE | Jan 13, 1986 | Substantially Equivalent | G.B.F. INDUSTRIES, INC. |
| K851885 | OMIDERM WOUND & BURN DRESSING | Nov 25, 1985 | Substantially Equivalent for Some Indications | BIOSYSTEMS ASSOC. |
| K853844 | DUODERM HYDROACTIVE DRESSING W/BORDER STERILE | Nov 15, 1985 | Substantially Equivalent for Some Indications | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K854344 | AQUACEL SURGICAL PREP PADS | Nov 13, 1985 | Substantially Equivalent | ADVANCED ORTHO-TECHNOLOGY, INC. |
| K852750 | TEGADERM PLUS TRANSPARENT DRESSING #952X | Sep 19, 1985 | Unknown | 3M COMPANY |
| K852545 | BAND-AID BRAND ADHESIVE BANDAGES | Sep 05, 1985 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K852614 | ATRAUM WOUND DRESSING | Aug 30, 1985 | Substantially Equivalent | AXIOM MEDICAL, INC. |
| K853334 | NON-ADHERA ADHESIVE PAD 3X4 | Aug 21, 1985 | Substantially Equivalent | AMERICAN WHITE CROSS, INC. |
| K852211 | OPSITE WOUND DRESSING | Jul 23, 1985 | Substantially Equivalent for Some Indications | SMITH & NEPHEW, INC. |
| K851383 | BLISTERFILM TRANSPARENT DRESSING | Jul 05, 1985 | Substantially Equivalent for Some Indications | CHESEBROUGH-POND'S U.S.A. CO. |
| K851382 | CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING | Jul 05, 1985 | Substantially Equivalent for Some Indications | CHESEBROUGH-POND'S U.S.A. CO. |
| K850889 | BARD OCCLUSIVE WOUND DRESSING | Jul 05, 1985 | Substantially Equivalent for Some Indications | C.R. BARD, INC. |
| K850147 | CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE | Jul 05, 1985 | Substantially Equivalent for Some Indications | BEIERSDORF, INC. |
| K852091 | ALBA DRY BURN PAD | Jun 13, 1985 | Substantially Equivalent | ALBA-WALDENSIAN, INC. |
| K850535 | MITRATHANE DRESSING | Jun 05, 1985 | Substantially Equivalent for Some Indications | MITRAL MEDICAL LTD. |
| K850451 | J & J ULCER DRESSING | Jun 05, 1985 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K843206 | COOK COUNTY HOSPITAL DRESSING CHANGE SET | May 24, 1985 | Substantially Equivalent | GENEVA LABORATORIES, INC. |
| K850819 | GELIPERM ABSORBIND GRANULATED GEL | May 07, 1985 | Substantially Equivalent | GEISTLICH-PHARMA |
| K850282 | HYPAFIX POST OPERATIVE DRESSING | May 07, 1985 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K850126 | OIL EMULSION NON-ADHERING DRESSING | Apr 25, 1985 | Substantially Equivalent | ABSORBENT COTTON CO., INC. |
| K850904 | ALBA DRY BURN DRESSING | Apr 17, 1985 | Substantially Equivalent | ALBA HEALTH CARE |
| K850076 | WOUND DRESSING MODEL ZB-6 | Apr 15, 1985 | Substantially Equivalent | THERMEDICS, INC. |
| K850241 | ALBA HEALTH CARE NON-ADHERING DRESSING | Mar 12, 1985 | Substantially Equivalent | ALBA HEALTH CARE |
| K843200 | SITE STRIP | Mar 12, 1985 | Substantially Equivalent | E-MED CORP. |
| K844095 | WET DRESSING WATER-STERILE | Nov 27, 1984 | Substantially Equivalent | ABSORBENT COTTON CO., INC. |
| K844096 | WET DRESSING SALINE-STERILE | Nov 19, 1984 | Substantially Equivalent | ABSORBENT COTTON CO., INC. |
| K843140 | ISOLATE ADHESIVE BANDAGE FOR DRY WOUND | Nov 08, 1984 | Substantially Equivalent | CHESEBROUGH-POND'S U.S.A. CO. |
| K843139 | ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND | Nov 08, 1984 | Substantially Equivalent | CHESEBROUGH-POND'S U.S.A. CO. |
| K842967 | AQUAPHOR R GAUZE | Nov 08, 1984 | Substantially Equivalent | BEIERSDORF, INC. |
| K840438 | COMFEEL ULCUS SHEET | Nov 07, 1984 | Substantially Equivalent | COLOPLAST A/S |
| K843035 | SANG-A PETROLATUM GAUZE USP STERILE | Sep 20, 1984 | Substantially Equivalent | TECH-CONS LTD., INTL. |
| K842186 | ACU-DERM TRANSPARENT WOUND DRESSING | Aug 24, 1984 | Substantially Equivalent | ACME UNITED CORP. |
| K841287 | DUODERM FLEXIBLE HYDROACTIVE DRESSINGS | Aug 20, 1984 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K842064 | ACU-DERM TRANSPARENT IV DRESSING | Aug 15, 1984 | Substantially Equivalent | ACME UNITED CORP. |
| K832699 | HYDRON WOUND DRESSING FAST SEAT KIT | Apr 27, 1984 | Substantially Equivalent | NATIONAL PATENT DEVELOPMENT CORP. |
| K840745 | STERILE ABSORBENT GAUZE BURN & SOUND | Apr 23, 1984 | Substantially Equivalent | CHESEBROUGH-POND'S U.S.A. CO. |
| K822306 | BIO-BAND BANDAGES | Mar 15, 1984 | Substantially Equivalent | ROBERT HIRSCHFIELD |
| K833730 | NON ADHERENT BANDAGE/SHEET | Jan 27, 1984 | Substantially Equivalent | AMERICAN MEDICAL DISPOSABLE, INC. |
| K833075 | WET DRESSING KIT | Jan 27, 1984 | Substantially Equivalent | CLINIPAD CORP. |
| K834532 | STERILE WET DRESSING PACK | Jan 25, 1984 | Substantially Equivalent | W.G. WHITNEY CORP. |
| K832407 | DECUBITUS CARE ABSORBENT DRESSING | Jan 19, 1984 | Substantially Equivalent | AMERICAN PHARMASEAL DIV. AHSC |
| K831710 | BARD ABSORPTION DRESSING | Jan 03, 1984 | Substantially Equivalent | C.R. BARD, INC. |
| K833729 | ELASTIC BREATHABLE OVER-WRAP BANDAGE | Dec 30, 1983 | Substantially Equivalent | AMERICAN MEDICAL DISPOSABLE, INC. |
| K833733 | NON - ADHERENT BANDAGE | Dec 27, 1983 | Substantially Equivalent | AMERICAN MEDICAL DISPOSABLE, INC. |
| K833638 | DERMATEX STERILE FINGER BANDAGE | Dec 27, 1983 | Substantially Equivalent | DERMATEC, INC. |
| K831204 | MULTIPLE | Nov 28, 1983 | Substantially Equivalent | DERMA-LOCK MEDICAL CORP. |
| K831454 | LASTOBAND ADHESIVE BANDAGES | Oct 31, 1983 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K831657 | ALKA FIRST AID KIT | Aug 24, 1983 | Substantially Equivalent | ALKA, INC. |
| K831283 | TRIANGLE BANDAGE STERILE | Aug 12, 1983 | Substantially Equivalent | PAC-KIT SAFETY EQUIPMENT CO. |
| K823225 | GELIPERM GRANULES | Aug 12, 1983 | Substantially Equivalent | GEISTLICH-PHARMA |
| K822073 | GELIPERM DRY | Aug 12, 1983 | Substantially Equivalent | HAMEL, PARK, MCCABE & SAUNDERS |
| K822058 | GELIPERM TRANSPARENT GEL-FILM DRESSING | Aug 12, 1983 | Substantially Equivalent | HAMEL, PARK, MCCABE & SAUNDERS |
| K831611 | UNI-THANE | Jun 20, 1983 | Substantially Equivalent | CARAPAC SYSTEMS, INC. |
| K830050 | MOLNLYCKE MEPORE STERILE SELF-ADHESIVE | Jun 02, 1983 | Substantially Equivalent | LADA INTL., INC. |
| K830375 | FIRST AID BAGS #1,2,3 | May 25, 1983 | Substantially Equivalent | AKLA, INC. |
| K830825 | YIELD NON-ADHERENT DRESSING | May 13, 1983 | Substantially Equivalent | PROFESSIONAL MEDICAL PRODUCTS, INC. |
| K830374 | RESCUE PACK | May 13, 1983 | Substantially Equivalent | AKLA, INC. |
| K830373 | FIRST AID KIT | May 13, 1983 | Substantially Equivalent | AKLA, INC. |
| K830708 | DUO DERM FLEX HYDROACTIVE DRESSINGS & | May 05, 1983 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K830640 | BOO-BOO STRIP | May 04, 1983 | Substantially Equivalent | COLOSSUS CORP. |
| K822990 | CONVERTORS PRIMARY WOUND DRESSING II | Apr 12, 1983 | Substantially Equivalent | AMERICAN HOSPITAL SUPPLY CORP. |
| K830593 | ENSURE DRESSING | Apr 06, 1983 | Substantially Equivalent | WARNER-LAMBERT CO. |
| K823852 | CHESEBROUGH-POND'S MULTILAYER ELASTIC | Mar 17, 1983 | Substantially Equivalent | CHESEBROUGH-POND'S U.S.A. CO. |
| K830089 | BURN DRESSING | Mar 08, 1983 | Substantially Equivalent | ACTION MEDICAL SYSTEMS, INC. |
| K830166 | MOLNLYCKE ETE STERILE NON-ADHERENT DRESS | Feb 09, 1983 | Substantially Equivalent | LADA INTL., INC. |
| K830051 | MOLNLYCKE MESALT STERILE DRESSING | Jan 26, 1983 | Substantially Equivalent | LADA INTL., INC. |
| K822467 | PERFILM MEMBRANE DRESSING | Dec 30, 1982 | Substantially Equivalent | CHESEBROUGH-POND'S U.S.A. CO. |
| K822424 | CURITY TRANSPARENT FILM DRESSING | Dec 17, 1982 | Substantially Equivalent | THE KENDAL CO. |
| K822080 | ADHESIVE WOUND COVER FILM | Oct 15, 1982 | Substantially Equivalent | HOLLISTER, INC. |
| K821655 | DUODERM HYDROACTIVE GRANULES | Oct 13, 1982 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K821656 | DUODERM FLEXIBLE HYDROACTIVE DRESSINGS | Sep 07, 1982 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K820635 | PVP GEL DRESSING | Aug 31, 1982 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K821258 | SELOPOR | Aug 19, 1982 | Substantially Equivalent | SELOMAS, INC. |
| K821246 | MELOLIN | Aug 06, 1982 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K820620 | BIOBRANE R II BRAND | Aug 03, 1982 | Substantially Equivalent | WOODROOF MFG., INC. |
| K822047 | INTERSORB DRY BURN VEST & PANTS | Jul 28, 1982 | Substantially Equivalent | CHESEBROUGH-POND'S U.S.A. CO. |
| K820470 | UNIFLEX | Jun 02, 1982 | Substantially Equivalent | HOWMEDICA CORP. |
| K820413 | AEGIS NON-ADHERENT DRESSING | Mar 12, 1982 | Substantially Equivalent | PROFESSIONAL MEDICAL PRODUCTS, INC. |
| K820198 | DERMA-AID | Mar 05, 1982 | Substantially Equivalent | WINFIELD LABORATORIES, INC. |
| K820139 | SOF-ROL CAST PADDING | Feb 05, 1982 | Substantially Equivalent | STAN-PAK ENT. |
| K820105 | COMBINE PAD OR ABD | Feb 05, 1982 | Substantially Equivalent | STAN-PAK ENT. |
| K820056 | TELFA STRIPS | Feb 05, 1982 | Substantially Equivalent | STAN-PAK ENT. |
| K820098 | ROLLER GAUZE | Feb 04, 1982 | Substantially Equivalent | STAN-PAK ENT. |
| K820097 | SHEET WADDING CAST PADDING | Feb 04, 1982 | Substantially Equivalent | STAN-PAK ENT. |
| K820096 | VAG PACKING | Feb 04, 1982 | Substantially Equivalent | STAN-PAK ENT. |
| K813535 | XEROFORM DRESSING | Feb 04, 1982 | Substantially Equivalent | W.G. WHITNEY CORP. |
| K813365 | MULTIPLE BANDAGE OR DRESSING | Feb 04, 1982 | Substantially Equivalent | CEDERROTH, INC. USA |
| K812678 | TEGADERM TRANSPARENT DRESSING | Jan 25, 1982 | Substantially Equivalent | 3M COMPANY |
| K813419 | COMFORT CUSHION DRY BURN PAD III | Jan 22, 1982 | Substantially Equivalent | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
| K813308 | DOUBLE SEAL TUBEGUAZE STERILE BANDAGE | Dec 29, 1981 | Substantially Equivalent | SCHOLL, INC. |
| K812073 | DESERET CATHETER DRESSING | Oct 06, 1981 | Substantially Equivalent | WARNER-LAMBERT CO. |
| K812501 | OPRAFLEX | Oct 02, 1981 | Substantially Equivalent | SELOMAS, INC. |
| K810902 | IP-758 BURN WOUND DRESSING | Sep 11, 1981 | Substantially Equivalent | EXOPACK |
| K811814 | TRIANGULAR BANDAGE | Jul 31, 1981 | Substantially Equivalent | ABCO DEALERS, INC. |
| K810050 | VECAFIX* | Mar 26, 1981 | Substantially Equivalent | POLLAK (INTL.), LTD. |
| K803115 | DRESSING CHANGE FOR G TUBE | Jan 06, 1981 | Substantially Equivalent | AMERICAN MEDICAL DISPOSABLE, INC. |
| K803119 | LARGE WOUND DRESSING KIT | Dec 30, 1980 | Substantially Equivalent | AMERICAN MEDICAL DISPOSABLE, INC. |
| K803117 | CUSTOM DRESSING TRAY WET TO DRY | Dec 23, 1980 | Substantially Equivalent | AMERICAN MEDICAL DISPOSABLE, INC. |
| K803118 | SIMPLE DRESSING TRAY #82028 | Dec 22, 1980 | Substantially Equivalent | AMERICAN MEDICAL DISPOSABLE, INC. |
| K803114 | HYPERALIMENTATION DRESSING CHANGE TRAY | Dec 22, 1980 | Substantially Equivalent | AMERICAN MEDICAL DISPOSABLE, INC. |
| K802793 | LOMATUELL OINTMENT DRESSING | Dec 18, 1980 | Substantially Equivalent | SECOL CO. |
| K802791 | ZINC PASTE BANDAGE | Dec 17, 1980 | Substantially Equivalent | SECOL CO. |
| K802017 | DRESSING CHANGE SET CAT.#910-930 | Oct 10, 1980 | Substantially Equivalent | POLLAK (INTL.), LTD. |
| K802021 | PEDIBAND CAT.#195-197 | Sep 16, 1980 | Substantially Equivalent | POLLAK (INTL.), LTD. |
| K802013 | FIRST AID BANDAGE CAT.#198 OR 199 | Sep 16, 1980 | Substantially Equivalent | POLLAK (INTL.), LTD. |
| K802006 | TRIANGULAR BANDAGE CAT.#191 | Sep 16, 1980 | Substantially Equivalent | POLLAK (INTL.), LTD. |
| K801996 | GUAZE BANDAGES CAT.#101-169 | Sep 16, 1980 | Substantially Equivalent | POLLAK (INTL.), LTD. |
| K801840 | SURGICAL BANDAGES/SUNLEEP DX | Sep 09, 1980 | Substantially Equivalent | MARTIN'S MAINE EXCHANGE |
| K801635 | BIOBRANE BRAND TEMPORARY WOUND-DRESSING | Aug 04, 1980 | Substantially Equivalent | HALL-WOODROOF, INC. |
| K800953 | FIXOMULL STERILE | May 20, 1980 | Substantially Equivalent | BEIERSDORF, INC. |
| K791573 | JELONET PARAFFIN GAUZE DRESSINGS | Sep 04, 1979 | Substantially Equivalent | ACME UNITED CORP. |
| K791369 | AIRSTRIP THEATRE WARD DRESSING | Aug 28, 1979 | Substantially Equivalent | ACME UNITED CORP. |
| K780795 | GAUZE SPONGES | Jun 06, 1978 | Substantially Equivalent | ABCO DEALERS, INC. |
| K780764 | NON-STERILE FOLDED GAUZE | Jun 06, 1978 | Substantially Equivalent | THE OWENBY CO. |
| K780549 | NON-STICK PADS | Apr 19, 1978 | Substantially Equivalent | NATIONAL PATENT DEVELOPMENT CORP. |
| K780394 | GAUZE FLUFF | Apr 10, 1978 | Substantially Equivalent | THE TORRENT CORP. |
| K780336 | URINE SAMPLE KIT | Apr 03, 1978 | Substantially Equivalent | AMERICAN HOSPITAL SUPPLY CORP. |
| K780222 | I.V. START KIT | Mar 28, 1978 | Substantially Equivalent | MARION LABORATORIES, INC. |
| K761093 | BANDAGE | Jan 06, 1977 | Substantially Equivalent | PACO PHARMACEUTICAL SERVICES, INC. |
| K760250 | BANDAGE, TRIANGULAR NO. 8068 | Jul 26, 1976 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
FEI Numbers
This FDA classification entry is associated with 402 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 403 registration numbers. Click on an entry to view related FDA registrations.