Product Code: FRO FDA unclassified

Dressing, Wound, Drug

Unknown

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.

View on FDA

510(k)s

703

FEI Numbers

384

Registration Numbers

385

Unique Applicants

348

Years Active

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Basic Information

Product Code: FRO
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 703 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261638	Bonvadis®	Jun 17, 2026	Substantially Equivalent	Oneness Biotech Co., Ltd.
K254073	StatSeal Disc	May 13, 2026	Substantially Equivalent	Merit Medical Systems, Inc.
K254191	IWD-Gel	Apr 07, 2026	Substantially Equivalent	InnovaCorium, Inc.
K252023	MiraChlor Antimicrobial Wound Solution	Mar 25, 2026	Substantially Equivalent	Letus Corporation
K251999	Promogran Prisma Collagen Matrix with ORC and Silver	Mar 13, 2026	Substantially Equivalent	Solventum Germany GmbH
K252028	LUOFUCON® Antimicrobial Wound Gel	Mar 11, 2026	Substantially Equivalent	Huizhou Foryou Medical Co., Ltd.
K251582	Redermax Antibacterial Wound Matrix	Feb 02, 2026	Substantially Equivalent	Beijing Kreate Medical Co., Ltd.
K252568	New Day Skin Spray	Jan 23, 2026	Substantially Equivalent	Silk Holdings, Inc.
K250890	SBC1 Cream	Jan 12, 2026	Substantially Equivalent	Sioxmed, LLC
K252759	revyve® Antimicrobial Skin and Wound Cleanser	Jan 08, 2026	Substantially Equivalent	Kane Biotech, Inc.
K251757	Puracyn® Plus Antimicrobial Irrigation Solution	Jan 05, 2026	Substantially Equivalent	Innovacyn, Inc.
K252167	Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)	Dec 19, 2025	Substantially Equivalent	Qingdao Bright Moon Biomedical Materials Co., Ltd.
K250642	LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)	Nov 19, 2025	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.
K250115	Hemastyl() Wound Dressing	Oct 14, 2025	Substantially Equivalent	Rapid Nexus Nanotech Wound Solutions, Inc.
K251866	Tegaderm Post-Op Transparent Antimicrobial Dressing	Oct 10, 2025	Substantially Equivalent	Solventum US, LLC
K243166	Dermalage	Aug 27, 2025	Substantially Equivalent	Infection Elimination Solutions, LLC
K243415	Granudacyn® Wound Irrigation Solution	Jul 22, 2025	Substantially Equivalent	P.G.F. Industry Solutions GmbH
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.
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.
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.
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.
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
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.
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.
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
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.
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 Healthcare 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.
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.
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 Healthcare
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
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.
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
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.
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
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 Wound Care 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	Covalontechnologies, 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.
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	Covalontechnologies, 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.
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, LLC
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.
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.
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
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, LLC
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.
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.
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.
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.
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	Covalontechnologies, 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.
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.
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)
K013462	HYDROFERA BACTERIOSTATIC WOUND DRESSING	Jan 11, 2002	Substantially Equivalent	Hydrofera, LLC
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.
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.
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
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.
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.
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
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
K905314	ALGODERM ALGINATE WOUND DRESSING	Feb 19, 1991	Substantially Equivalent	Les Laboratorires Brothier, S.A.
K904852	DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK	Jan 25, 1991	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
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.
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.
K896702	WOUND DRESSING	Jan 19, 1990	Substantially Equivalent	Viaderm Pharmaceuticals, 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.
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.
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.
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.
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.
K892232	ACTIDERM*-OPAQUE	May 05, 1989	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K890545	NU-DERM HYDROCOLLOID DRESSING	Mar 23, 1989	Substantially Equivalent for Some Indications	Johnson & Johnson Patient Care, Inc.
K885321	WATER JEL STERILE GEL-SOAKED BURN DRESSING	Mar 22, 1989	Substantially Equivalent for Some Indications	Pfizer Pharmaceuticals
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.
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
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
K881854	SORBSAN TOPICAL WOUND DRESSING	Jul 19, 1988	Substantially Equivalent	E.G. Dick & Assoc.
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
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.
K880299	REPLICARE	Feb 26, 1988	Substantially Equivalent	United Medical
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.
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
K871327	D.R.P. THREE STEP WOUND DRESSING	Nov 09, 1987	Substantially Equivalent for Some Indications	Bioderm, 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.
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
K871255	MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSING	May 29, 1987	Substantially Equivalent for Some Indications	Hercon Laboratories Corp.
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.
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.
K863930	VISCOPASTE ZINC PASTE BANDAGE	Dec 01, 1986	Substantially Equivalent for Some Indications	Smith & Nephew, 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
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.
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.
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.
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.
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.
K850451	J & J ULCER DRESSING	Jun 05, 1985	Substantially Equivalent for Some Indications	Johnson & Johnson Professionals, Inc.
K850819	GELIPERM ABSORBIND GRANULATED GEL	May 07, 1985	Substantially Equivalent	Geistlich-Pharma
K850126	OIL EMULSION NON-ADHERING DRESSING	Apr 25, 1985	Substantially Equivalent	Absorbent Cotton Co., Inc.
K850241	ALBA HEALTH CARE NON-ADHERING DRESSING	Mar 12, 1985	Substantially Equivalent	Alba Health Care
K844096	WET DRESSING SALINE-STERILE	Nov 19, 1984	Substantially Equivalent	Absorbent Cotton Co., Inc.
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.
K841287	DUODERM FLEXIBLE HYDROACTIVE DRESSINGS	Aug 20, 1984	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
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.
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.
K833733	NON - ADHERENT BANDAGE	Dec 27, 1983	Substantially Equivalent	American Medical Disposable, Inc.
K831657	ALKA FIRST AID KIT	Aug 24, 1983	Substantially Equivalent	Alka, Inc.
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
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.
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.
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.
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.
K820620	BIOBRANE R II BRAND	Aug 03, 1982	Substantially Equivalent	Woodroof Mfg., Inc.
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
K812501	OPRAFLEX	Oct 02, 1981	Substantially Equivalent	Selomas, Inc.
K803115	DRESSING CHANGE FOR G TUBE	Jan 06, 1981	Substantially Equivalent	American Medical Disposable, Inc.
K803114	HYPERALIMENTATION DRESSING CHANGE TRAY	Dec 22, 1980	Substantially Equivalent	American Medical Disposable, Inc.
K802791	ZINC PASTE BANDAGE	Dec 17, 1980	Substantially Equivalent	Secol Co.
K801635	BIOBRANE BRAND TEMPORARY WOUND-DRESSING	Aug 04, 1980	Substantially Equivalent	Hall-Woodroof, Inc.
K791573	JELONET PARAFFIN GAUZE DRESSINGS	Sep 04, 1979	Substantially Equivalent	Acme United Corp.
K780222	I.V. START KIT	Mar 28, 1978	Substantially Equivalent	Marion Laboratories, Inc.