Panels › General, Plastic Surgery › Product code FTM · Class 2
Mesh, Surgical
Regulation 878.3300
1510(k)s in 12 months (164 all time)
0recalls in 12 months (76 all time)
72recalls that name a 510(k)
Top companies in FTM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 12, 2026 | K262406 | EluPro Antibiotic-Eluting BioEnvelope Boston Scientific | FTM |
| Jun 3, 2025 | K250598 | Endoform Reconstructive Template - PLGA Aroa Biosurgery , Ltd., NZ | FTM |
| Dec 19, 2024 | K243595 | OviTex PRS (Long-Term Resorbable) TELA Bio, Inc. | FTM |
| Jun 14, 2024 | K233991 | CanGaroo RM Antibacterial Envelope Elutia, Inc. | FTM |
| May 22, 2024 | K241126 | OviTex PRS TELA Bio, Inc. | FTM |
| Apr 7, 2023 | K223052 | Peri-Guard and Supple Peri-Guard Synovis Life Technologies, Inc. | FTM |
| Mar 21, 2023 | K214070 | OviTex PRS (Long Term Resorbable) Tela Bio | FTM |
| Oct 29, 2021 | K213163 | VersaWrap Alafair Biosciences, Inc. | FTM |
| Oct 27, 2021 | K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology Synovis Life Technologies. Inc. (A Subsidiary of Baxter | FTM |
| Jul 14, 2021 | K203496 | Nexo-Gide Bilayer Collagen Membrane Geistlich Pharma AG, CH | FTM |
| Mar 9, 2021 | K203600 | VersaWrap Alafair Biosciences, Inc. | FTM |
| Sep 3, 2020 | K192452 | Lyograft B. Bruan Surgical, SA, ES | FTM |
| Jul 13, 2020 | K201000 | Biodesign Staple Line Reinforcement Cook Biotech Incorporated | FTM |
| Jun 15, 2020 | K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGa Aziyo Biologics, Inc. | FTM |
| Mar 6, 2020 | K200311 | VersaWrap Tendon Protector Alafair Biosciences, Inc. | FTM |
| Dec 17, 2019 | K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) Synovis Life Technologies, Inc. (Baxter International Inc.) | FTM |
| Oct 21, 2019 | K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGa Aziyo Biologics, Inc. | FTM |
| Jun 18, 2019 | K182493 | Bovine Pericardial Tissue Patch Tisgenx | FTM |
| Apr 11, 2019 | K183398 | Endoform Restella Aroa Biosurgery , Ltd., NZ | FTM |
| Mar 13, 2019 | K183472 | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional Synthes (USA) Products, LLC | FTM |
| Feb 7, 2019 | K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal Acell, Inc. | FTM |
| Nov 15, 2018 | K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro En Aziyo Biologics, Inc. | FTM |
| Mar 13, 2018 | K171817 | Biodesign Diaphragmatic Hernia Graft Cook Biotech Incorporated | FTM |
| Oct 25, 2017 | K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) Aziyo Biologics, Inc. | FTM |
| Oct 25, 2017 | K172937 | Colorado Therapeutics Xenograft Implant Colorado Therapeutics, LLC | FTM |
| Jul 10, 2017 | K162934 | Biodesign Parastomal Hernia Repair Graft Cook Biotech Incorporated | FTM |
| Jun 21, 2017 | K170016 | Biodesign Fistula Plug Cook Biotech Incorporated | FTM |
| Jun 8, 2017 | K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend Acell, Inc. | FTM |
| Feb 24, 2017 | K162752 | ARTIA Reconstructive Tissue Matrix Perforated Lifecell Corporation | FTM |
| Feb 16, 2017 | K162965 | SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction Tei Biosciences, Inc. | FTM |
| Feb 16, 2017 | K162570 | Miromatrix Biological Mesh TW Miromatrix Medical, Inc. | FTM |
| Feb 3, 2017 | K162388 | CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) Curaseal, Inc. | FTM |
| Dec 20, 2016 | K162461 | Endoform Plastics and Reconstructive Matrix Aroa Biosurgery (Formerly Mesynthes Limited), NZ | FTM |
| Oct 21, 2016 | K162554 | Gentrix Surgical Matrix Acell, Inc. | FTM |
| Oct 20, 2016 | K160181 | COLORADO THERAPEUTICS XENOGRAFT IMPLANT Colorado Therapeutics, LLC | FTM |
| May 26, 2016 | K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug Cook Biotech Incorporated | FTM |
| Apr 29, 2016 | K160869 | Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft Cook Biotech Incorporated | FTM |
| Mar 15, 2016 | K153633 | Endoform Reconstructive Template Aroa Biosurgery Limited (Formerly Mesynthes Limited), NZ | FTM |
| Mar 8, 2016 | K152206 | SurgiPure XD Reconstructive Tissue Matrix Tissue Regenix Group Plc, GB | FTM |
| Dec 9, 2015 | K150668 | Biodesign Enterocutaneous Fistula Plug Cook Biotech Incorprated | FTM |
| Oct 1, 2015 | K142887 | SIS Inguinal Hernia Repair Graft Cook Biotech Incorprated | FTM |
| Jul 2, 2015 | K150712 | LTM-Perforated Surgical Mesh Lifecell Corporation | FTM |
| Jun 17, 2015 | K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix Acell, Inc. | FTM |
| Dec 23, 2014 | K142326 | HP Tissue Matrix Lifecell Corporation | FTM |
| Dec 22, 2014 | K141721 | BOVINE PERICARDIUM PATCH Collafirm, LLC | FTM |
| Dec 11, 2014 | K141053 | OVINE TISSUE MATRIX(OTM) TELA Bio, Inc. | FTM |
| Oct 27, 2014 | K142070 | FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS Rti Surgical, Inc. | FTM |
| Aug 15, 2014 | K140306 | CORMATRIX PROTECT ECM ENVELOPE Cormatrix Cardiovascular, Inc. | FTM |
| Jul 23, 2014 | K133306 | SIS HERNIA GRAFT Cook Biotech, Inc. | FTM |
| Apr 28, 2014 | K140501 | XENMATRIX SURGICAL GRAFT C. R. Bard | FTM |
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