Product Code: FTM
FDA class 2
21 CFR 878.3300
Mesh, Surgical
General, Plastic Surgery
A surgical mesh is a woven or knitted implantable material used to provide structural support during tissue repair or reconstruction procedures, including hernia and pelvic floor repair. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FTM, regulated under 21 CFR 878.3300, within the General, Plastic Surgery medical specialty. This device is designated as an implant.
510(k)s
163
FEI Numbers
89
Registration Numbers
89
Unique Applicants
81
Years Active
43
Basic Information
- Product Code
- FTM
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 163 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250598 | Endoform Reconstructive Template - PLGA | Jun 03, 2025 | Substantially Equivalent | Aroa Biosurgery Ltd. |
| K243595 | OviTex PRS (Long-Term Resorbable) | Dec 19, 2024 | Substantially Equivalent | TELA Bio, Inc. |
| K233991 | CanGaroo RM Antibacterial Envelope | Jun 14, 2024 | Substantially Equivalent | Elutia Inc. |
| K241126 | OviTex PRS | May 22, 2024 | Substantially Equivalent | Tela Bio, Inc. |
| K223052 | Peri-Guard and Supple Peri-Guard | Apr 07, 2023 | Substantially Equivalent | Synovis Life Technologies, Inc. |
| K214070 | OviTex PRS (Long Term Resorbable) | Mar 21, 2023 | Substantially Equivalent | TELA Bio |
| K213163 | VersaWrap | Oct 29, 2021 | Substantially Equivalent | Alafair Biosciences Inc |
| K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology | Oct 27, 2021 | Substantially Equivalent | Synovis Life Technologies. Inc. (A Subsidiary Of Baxter |
| K203496 | Nexo-Gide Bilayer Collagen Membrane | Jul 14, 2021 | Substantially Equivalent | Geistlich Pharma AG |
| K203600 | VersaWrap | Mar 09, 2021 | Substantially Equivalent | Alafair Biosciences Inc |
| K192452 | Lyograft | Sep 03, 2020 | Substantially Equivalent | B. Bruan Surgical, SA |
| K201000 | Biodesign Staple Line Reinforcement | Jul 13, 2020 | Substantially Equivalent | Cook Biotech Incorporated |
| K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) | Jun 15, 2020 | Substantially Equivalent | Aziyo Biologics, Inc. |
| K200311 | VersaWrap Tendon Protector | Mar 06, 2020 | Substantially Equivalent | Alafair Biosciences Inc |
| K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) | Dec 17, 2019 | Substantially Equivalent | Synovis Life Technologies, Inc. (Baxter International Inc.) |
| K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) | Oct 21, 2019 | Substantially Equivalent | Aziyo Biologics, Inc. |
| K182493 | Bovine Pericardial Tissue Patch | Jun 18, 2019 | Substantially Equivalent | Tisgenx |
| K183398 | Endoform Restella | Apr 11, 2019 | Substantially Equivalent | Aroa Biosurgery Ltd. |
| K183472 | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional | Mar 13, 2019 | Substantially Equivalent | Synthes (USA) Products LLC |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | Feb 07, 2019 | Substantially Equivalent | ACell, Inc. |
| K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) | Nov 15, 2018 | Substantially Equivalent | Aziyo Biologics, Inc. |
| K171817 | Biodesign Diaphragmatic Hernia Graft | Mar 13, 2018 | Substantially Equivalent | Cook Biotech Incorporated |
| K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) | Oct 25, 2017 | Substantially Equivalent | Aziyo Biologics, Inc. |
| K172937 | Colorado Therapeutics Xenograft Implant | Oct 25, 2017 | Substantially Equivalent | Colorado Therapeutics LLC |
| K162934 | Biodesign Parastomal Hernia Repair Graft | Jul 10, 2017 | Substantially Equivalent | Cook Biotech Incorporated |
| K170016 | Biodesign Fistula Plug | Jun 21, 2017 | Substantially Equivalent | Cook Biotech Incorporated |
| K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend | Jun 08, 2017 | Substantially Equivalent | ACell, Inc. |
| K162752 | ARTIA Reconstructive Tissue Matrix Perforated | Feb 24, 2017 | Substantially Equivalent | LIFECELL CORPORATION |
| K162965 | SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | Feb 16, 2017 | Substantially Equivalent | TEI Biosciences Inc. |
| K162570 | Miromatrix Biological Mesh TW | Feb 16, 2017 | Substantially Equivalent | Miromatrix Medical Inc. |
| K162388 | CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) | Feb 03, 2017 | Substantially Equivalent | CURASEAL, INC. |
| K162461 | Endoform Plastics and Reconstructive Matrix | Dec 20, 2016 | Substantially Equivalent | AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED) |
| K162554 | Gentrix Surgical Matrix | Oct 21, 2016 | Substantially Equivalent | Acell, Inc. |
| K160181 | COLORADO THERAPEUTICS XENOGRAFT IMPLANT | Oct 20, 2016 | Substantially Equivalent | Colorado Therapeutics LLC |
| K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | May 26, 2016 | Substantially Equivalent | Cook Biotech Incorporated |
| K160869 | Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft | Apr 29, 2016 | Substantially Equivalent | COOK BIOTECH INCORPORATED |
| K153633 | Endoform Reconstructive Template | Mar 15, 2016 | Substantially Equivalent | Aroa Biosurgery Limited (Formerly Mesynthes Limited) |
| K152206 | SurgiPure XD Reconstructive Tissue Matrix | Mar 08, 2016 | Substantially Equivalent | TISSUE REGENIX GROUP PLC |
| K150668 | Biodesign Enterocutaneous Fistula Plug | Dec 09, 2015 | Substantially Equivalent | COOK BIOTECH INCORPRATED |
| K142887 | SIS Inguinal Hernia Repair Graft | Oct 01, 2015 | Substantially Equivalent | COOK BIOTECH INCORPRATED |
| K150712 | LTM-Perforated Surgical Mesh | Jul 02, 2015 | Substantially Equivalent | LifeCell Corporation |
| K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | Jun 17, 2015 | Substantially Equivalent | ACELL, INC |
| K142326 | HP Tissue Matrix | Dec 23, 2014 | Substantially Equivalent | LifeCell Corporation |
| K141721 | BOVINE PERICARDIUM PATCH | Dec 22, 2014 | Substantially Equivalent | COLLAFIRM LLC |
| K141053 | OVINE TISSUE MATRIX(OTM) | Dec 11, 2014 | Substantially Equivalent | TELA BIO, INC. |
| K142070 | FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS | Oct 27, 2014 | Substantially Equivalent | RTI SURGICAL, INC. |
| K140306 | CORMATRIX PROTECT ECM ENVELOPE | Aug 15, 2014 | Substantially Equivalent | CORMATRIX CARDIOVASCULAR, INC. |
| K133306 | SIS HERNIA GRAFT | Jul 23, 2014 | Substantially Equivalent | COOK BIOTECH, INC. |
| K140501 | XENMATRIX SURGICAL GRAFT | Apr 28, 2014 | Substantially Equivalent | C.R. BARD |
| K134033 | MIROMATRIX BIOLOGICAL MESH | Mar 31, 2014 | Substantially Equivalent | MIROMATRIX MEDICAL INC. |
| K132025 | MESO BILAYER SURGICAL MESH | Oct 30, 2013 | Substantially Equivalent | KENSEY NASH CORPORATION DBA DSM BIOMEDICAL |
| K130547 | ENDOFORM RECONSTRUCTIVE TEMPLATE | May 31, 2013 | Substantially Equivalent | MESYNTHE LTD |
| K123356 | FORTIVA PORCINE DERMIS | Mar 05, 2013 | Substantially Equivalent | RTI BIOLOGICS, INC. |
| K122048 | COLLAGEN TENDON SHEET-D | Jan 08, 2013 | Substantially Equivalent | ROTATION MEDICAL, INC. |
| K120605 | PERMACOL SURGICAL IMPLANT | May 18, 2012 | Substantially Equivalent | Covidien LLC |
| K120019 | COLLAGEN RIBBON | Feb 23, 2012 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K113460 | SYNERGY TISSUE MATRIX | Jan 11, 2012 | Substantially Equivalent | SYNOVIS ORTHOPEDIC & WOUNDCARE |
| K110581 | PROPATCH SOFT TISSUE REPAIR MATRIX | Jan 10, 2012 | Substantially Equivalent | CRYOLIFE, INC. |
| K112423 | COLLAGEN TENDON SHEET | Dec 22, 2011 | Substantially Equivalent | ROTATION MEDICAL, INC. |
| K112786 | PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF | Oct 25, 2011 | Substantially Equivalent | SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC. |
| K111436 | PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX | Oct 14, 2011 | Substantially Equivalent | BRENNEN MEDICAL, LLC |
| K111584 | XYLOS MACRO-POROUS SURGICAL MESH | Aug 25, 2011 | Substantially Equivalent | XYLOS CORPORATION |
| K110402 | BIODESIGN NIPPLE RECONSTRUCTION CYLINDER | Jun 20, 2011 | Substantially Equivalent | COOK BIOTECH, INC. |
| K103787 | MEDEOR MATRIX | Feb 07, 2011 | Substantially Equivalent | KENSEY NASH CORP. |
| K101587 | PROPATCH SOFT TISSUE REPAIR MATRIX | Sep 16, 2010 | Substantially Equivalent | CRYOLIFE, INC. |
| K094061 | KENSEY NASH ECM SURGICAL PATCH | May 18, 2010 | Substantially Equivalent | KENSEY NASH CORPORATION |
| K091499 | MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) | Oct 22, 2009 | Substantially Equivalent | KENSEY NASH CORP. |
| K091142 | TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 | Aug 31, 2009 | Substantially Equivalent | RTI BIOLOGICS, INC. |
| K090880 | XYLOS POROUS SURGICAL MESH | May 27, 2009 | Substantially Equivalent | XYLOS CORPORATION |
| K090778 | MTA PROTECTIVE SHEET | Apr 28, 2009 | Substantially Equivalent | XYLOS CORPORATION |
| K083823 | SECURIAN TISSUE REINFORCEMENT MATRIX | Mar 18, 2009 | Substantially Equivalent | XYLOS CORPORATION |
| K082682 | SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG | Feb 27, 2009 | Substantially Equivalent | COOK BIOTECH, INC. |
| K083898 | SURGIMEND | Feb 04, 2009 | Substantially Equivalent | TEI BIOSCIENCES INC. |
| K083039 | VERITAS COLLAGEN MATRIX (DRY) | Nov 26, 2008 | Substantially Equivalent | SYNOVIS SURGICAL INNOVATIONS |
| K082176 | LTM-BPS SURGICAL MESH | Nov 14, 2008 | Substantially Equivalent | LIFECELL CORP. |
| K082687 | COLLAMEND FM IMPLANT | Oct 17, 2008 | Substantially Equivalent | C.R. BARD, INC. |
| K081272 | PORCINE SURGICAL MESH; DERMAL MATRIX | Jul 31, 2008 | Substantially Equivalent | BRENNEN MEDICAL, LLC |
| K081882 | MODIFICATION TO XYLOS SURGICAL MESH | Jul 11, 2008 | Substantially Equivalent | XYLOS CORPORATION |
| K081538 | TUTOPATCH, TUTOMESH | Jun 19, 2008 | Substantially Equivalent | RTI BIOLOGICS, INC. |
| K080452 | COLLAGEN TENDON WRAP | May 15, 2008 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K073219 | WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 | Apr 10, 2008 | Substantially Equivalent | AMERICAN MEDICAL SYSTEMS, INC. |
| K073391 | SURGISIS BIODESIGN TISSUE GRAFT | Mar 21, 2008 | Substantially Equivalent | COOK BIOTECH, INC. |
| K071986 | LTM-RC SURGICAL MESH | Oct 19, 2007 | Substantially Equivalent | LIFECELL CORP. |
| K070405 | MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT | Oct 17, 2007 | Substantially Equivalent | COOK BIOTECH, INC. |
| K071016 | DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT | Sep 04, 2007 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K071807 | ORTHOMEND SOFT TISSUE MATRIX | Aug 06, 2007 | Substantially Equivalent | TEI BIOSCIENCES INC. |
| K062558 | MESOSFOL SURGICAL FILM | Jun 20, 2007 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K070560 | LRTM SURGICAL MESH | Jun 11, 2007 | Substantially Equivalent | LIFECELL CORP. |
| K071065 | ORTHADAPT BIOIMPLANT | May 04, 2007 | Substantially Equivalent | PEGASUS BIOLOGICS, INC. |
| K070738 | SIS FACIAL CYLINDER, SIS FACIAL IMPLANT | Apr 05, 2007 | Substantially Equivalent | COOK BIOTECH, INC. |
| K063556 | PERIPATCH ENDO-SLEEVE | Mar 20, 2007 | Substantially Equivalent | PM DEVICES, INC. |
| K062915 | VERITAS COLLAGEN MATRIX | Dec 06, 2006 | Substantially Equivalent | SYNOVIS SURGICAL INNOVATIONS |
| K061892 | PROPATCH SOFT TISSUE REPAIR MATRIX | Nov 22, 2006 | Substantially Equivalent | CRYOLIFE, INC. |
| K063178 | BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 | Nov 21, 2006 | Substantially Equivalent | C.R. BARD, INC. |
| K062696 | SURGISIS, SURGISIS ES | Oct 13, 2006 | Substantially Equivalent | COOK BIOTECH, INC. |
| K062729 | SURGISIS RVP RECTO-VAGINAL FISTULA PLUG | Oct 10, 2006 | Substantially Equivalent | COOK BIOTECH, INC. |
| K062320 | SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 | Oct 02, 2006 | Substantially Equivalent | COOK BIOTECH, INC. |
| K053562 | ZIMMER COLLAGEN REPAIR PATCH | Jun 23, 2006 | Substantially Equivalent | TISSUE SCIENCE LABORATORIES, PLC |
| K060984 | XENFORM SOFT TISSUE REPAIR MATRIX | May 17, 2006 | Substantially Equivalent | TEI BIOSCIENCES INC. |
| K060829 | COSMATRIX | May 17, 2006 | Substantially Equivalent | TEI BIOSCIENCES INC. |
| K060989 | TISSUEMEND SOFT TISSUE REPAIR MATRIX | May 15, 2006 | Substantially Equivalent | TEI BIOSCIENCES INC. |
| K061030 | BIOBLANKET SURGICAL MESH | May 09, 2006 | Substantially Equivalent | KENSEY NASH CORPORATION |
| K052322 | BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105 | Apr 10, 2006 | Substantially Equivalent | C.R. BARD, INC. |
| K053655 | TENDON WRAP TENDON PROTECTOR | Feb 03, 2006 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K051879 | SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS | Oct 05, 2005 | Substantially Equivalent | SYNTHES (USA) |
| K051048 | SURGISIS STAPLE LINE REINFORCEMENT II | Sep 23, 2005 | Substantially Equivalent | COOK BIOTECH, INC. |
| K043259 | BIOBLANKET SURGICAL MESH | Aug 15, 2005 | Substantially Equivalent | KENSEY NASH CORP. |
| K043388 | PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH | Aug 05, 2005 | Substantially Equivalent | PEGASUS BIOLOGICS, INC. |
| K050246 | SIS DERMAL AUGMENTATION STRAND | May 19, 2005 | Substantially Equivalent | COOK BIOTECH, INC. |
| K050337 | SIS FISTULA PLUG | Mar 09, 2005 | Substantially Equivalent | COOK BIOTECH, INC. |
| K042809 | CUFFPATCH | Nov 02, 2004 | Substantially Equivalent | ORGANOGENESIS, INC. |
| K041669 | VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD | Oct 27, 2004 | Substantially Equivalent | SYNOVIS SURGICAL INNOVATIONS |
| K041923 | BIOBLANKET | Sep 08, 2004 | Substantially Equivalent | KENSEY NASH CORP. |
| K040756 | THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX | Jul 14, 2004 | Substantially Equivalent | IMPLEX CORP. |
| K041140 | ACELL UBM SURGICAL MESH ML AND MLPLUS | Jul 07, 2004 | Substantially Equivalent | ACELL, INC |
| K040364 | MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH | Jun 30, 2004 | Substantially Equivalent | POREX SURGICAL, INC. |
| K040835 | PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16 | Jun 15, 2004 | Substantially Equivalent | PM DEVICES, INC. |
| K040868 | SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH | Jun 04, 2004 | Substantially Equivalent | GENZYME CORP. |
| K033985 | PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10 | Jun 04, 2004 | Substantially Equivalent | PM DEVICES, INC. |
| K040621 | ACELL UBM SURGICAL MESH | Apr 14, 2004 | Substantially Equivalent | ACELL, INC |
| K040119 | PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION | Mar 17, 2004 | Substantially Equivalent | SYNOVIS SURGICAL INNOVATIONS |
| K034039 | SIS PLASTIC SURGERY MATRIX | Feb 18, 2004 | Substantially Equivalent | COOK BIOTECH, INC. |
| K031969 | DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT | Jul 28, 2003 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K031332 | BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH | May 15, 2003 | Substantially Equivalent | C.R. BARD, INC. |
| K030782 | SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | Apr 21, 2003 | Substantially Equivalent | W. L. GORE & ASSOCIATES, INC. |
| K023237 | XYLOS SURGICAL MESH | Mar 18, 2003 | Substantially Equivalent | XYLOS CORPORATION |
| K021056 | PERMACOL | Oct 31, 2002 | Substantially Equivalent | TISSUE SCIENCE LABORATORIES, PLC |
| K021160 | DERMMATRIX SURGICAL MESH | Jun 12, 2002 | Substantially Equivalent | CARBON MEDICAL TECHNOLOGIES, INC. |
| K021107 | FORTAFLEX SURGICAL SLING | May 15, 2002 | Substantially Equivalent | ORGANOGENESIS, INC. |
| K021105 | FORTAFLEX SURGICAL MESH | May 10, 2002 | Substantially Equivalent | ORGANOGENESIS, INC. |
| K020455 | TISSUEMEND SOFT TISSUE REPAIR MATRIX | Apr 03, 2002 | Substantially Equivalent | TEI BIOSCIENCES INC. |
| K020049 | FORTAFLEX SURGICAL MESH | Mar 18, 2002 | Substantially Equivalent | ORGANOGENESIS, INC. |
| K013625 | PERMACOL | Jan 17, 2002 | Substantially Equivalent | TISSUE SCIENCE LABORATORIES, PLC |
| K011025 | FORTAFLEX SURGICAL MESH | Aug 24, 2001 | Substantially Equivalent | ORGANOGENESIS, INC. |
| K011027 | FORTAFLEX SURGICAL SLING | May 30, 2001 | Substantially Equivalent | ORGANOGENESIS, INC. |
| K001738 | DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT | Dec 27, 2000 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K991296 | TUTOPATCH | Oct 06, 2000 | Substantially Equivalent | TUTOGEN MEDICAL U.S., INC. |
| K992537 | PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED | Feb 22, 2000 | Substantially Equivalent | BIO-VASCULAR, INC. |
| K991567 | SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. | Jul 14, 1999 | Substantially Equivalent | SHELHIGH, INC. |
| K983162 | PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC | Oct 09, 1998 | Substantially Equivalent | BIO-VASCULAR, INC. |
| K982330 | DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT | Sep 25, 1998 | Substantially Equivalent | DEPUY, INC. |
| K980431 | SURGISIS | May 28, 1998 | Substantially Equivalent | COOK BIOTECH, INC. |
| K973379 | STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS | Sep 25, 1997 | Substantially Equivalent | S. JACKSON, INC. |
| K971048 | PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT | May 09, 1997 | Substantially Equivalent | BIO-VASCULAR, INC. |
| K963175 | GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING | Sep 23, 1996 | Substantially Equivalent | GLYCAR, INC. |
| K961811 | PERI-GUARD PERICARDIUM | Jun 13, 1996 | Substantially Equivalent | BIO-VASCULAR, INC. |
| K961810 | SUPPLE PERI-GUARD PERICARDIUM | Jun 13, 1996 | Substantially Equivalent | BIO-VASCULAR, INC. |
| K940205 | PERI-STRIPS | May 02, 1994 | Substantially Equivalent | BIO-VASCULAR, INC. |
| K922308 | TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER | Jan 12, 1993 | Substantially Equivalent | TI-MESH, INC. |
| K923657 | SUPPLE PERI-GUARD | Dec 21, 1992 | Substantially Equivalent | BIO-VASCULAR, INC. |
| K915774 | PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH | Mar 02, 1992 | Substantially Equivalent | ETHICON, INC. |
| K896946 | COATED NOVAFIL, POLYBUTESTER, MESH | May 07, 1990 | Substantially Equivalent | AMERICAN CYANAMID CO. |
| K894580 | GORE-TEX SURGICAL TAPE | Oct 10, 1989 | Substantially Equivalent | W.L. GORE & ASSOCIATES,INC |
| K852011 | NYLAMID MESH PAD FULL & HALF | Jun 11, 1985 | Substantially Equivalent | S. JACKSON, INC. |
| K851086 | VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH | May 21, 1985 | Substantially Equivalent | ETHICON, INC. |
| K844228 | PDS POLYDIOXANONE MESH | Jan 24, 1985 | Substantially Equivalent | ETHICON, INC. |
| K844225 | LINK ACETABULAR MESH | Nov 14, 1984 | Substantially Equivalent | WALDEMAR LINK GMBH & CO. KG |
| K831725 | FOIL IN 3 FORMS-NON-STERILE SHEETS | Aug 16, 1983 | Substantially Equivalent | S. JACKSON, INC. |
| K831727 | QUARTER GLOBE CAPS | Aug 12, 1983 | Substantially Equivalent | S. JACKSON, INC. |
| K831723 | SUPRAMID EXTRA SURGICAL MESH | Aug 12, 1983 | Substantially Equivalent | S. JACKSON, INC. |
| K831726 | EYE MUSCLE SLEEVES | Aug 11, 1983 | Substantially Equivalent | S. JACKSON, INC. |
| K830889 | DEXON 'S' POLYGLYCOLIC ACID MESH | May 09, 1983 | Substantially Equivalent | DAVIS & GECK, INC. |
| K820619 | MECRON(R) ACETABULAR NETS TM | May 14, 1982 | Substantially Equivalent | SERRANO INTL. |
FEI Numbers
This FDA classification entry is associated with 89 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 89 registration numbers. Click on an entry to view related FDA registrations.