Atlas FDA

FTM

163 FDA 510(k) clearances · Product code

86 daysmedian time to decision
239 days90th percentile
163clearances measured

FDA profile

Official device name
Mesh, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2021: 369 · 2022: 375 · 2023: 485 · 2024: 384 · 2025: 233 · 2026: 112
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Endoform Reconstructive Template - PLGA (K250598)Aroa Biosurgery , Ltd.2025-06-03
OviTex PRS (Long-Term Resorbable) (K243595)TELA Bio, Inc.2024-12-19
CanGaroo RM Antibacterial Envelope (K233991)Elutia, Inc.2024-06-14
OviTex PRS (K241126)TELA Bio, Inc.2024-05-22
Peri-Guard and Supple Peri-Guard (K223052)Synovis Life Technologies, Inc.2023-04-07
OviTex PRS (Long Term Resorbable) (K214070)Tela Bio2023-03-21
VersaWrap (K213163)Alafair Biosciences, Inc.2021-10-29
PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (K213125)Synovis Life Technologies. Inc. (A Subsidiary of Baxter2021-10-27
Nexo-Gide Bilayer Collagen Membrane (K203496)Geistlich Pharma AG2021-07-14
VersaWrap (K203600)Alafair Biosciences, Inc.2021-03-09
Lyograft (K192452)B. Bruan Surgical, SA2020-09-03
Biodesign Staple Line Reinforcement (K201000)Cook Biotech Incorporated2020-07-13
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) (K201313)Aziyo Biologics, Inc.2020-06-15
VersaWrap Tendon Protector (K200311)Alafair Biosciences, Inc.2020-03-06
Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) (K192615)Synovis Life Technologies, Inc. (Baxter International Inc.)2019-12-17
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) (K192616)Aziyo Biologics, Inc.2019-10-21
Bovine Pericardial Tissue Patch (K182493)Tisgenx2019-06-18
Endoform Restella (K183398)Aroa Biosurgery , Ltd.2019-04-11
DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional (K183472)Synthes (USA) Products, LLC2019-03-13
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal (K182259)Acell, Inc.2019-02-07
CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) (K182255)Aziyo Biologics, Inc.2018-11-15
Biodesign Diaphragmatic Hernia Graft (K171817)Cook Biotech Incorporated2018-03-13
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) (K173242)Aziyo Biologics, Inc.2017-10-25
Colorado Therapeutics Xenograft Implant (K172937)Colorado Therapeutics, LLC2017-10-25
Biodesign Parastomal Hernia Repair Graft (K162934)Cook Biotech Incorporated2017-07-10
Biodesign Fistula Plug (K170016)Cook Biotech Incorporated2017-06-21
Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend (K170763)Acell, Inc.2017-06-08
ARTIA Reconstructive Tissue Matrix Perforated (K162752)Lifecell Corporation2017-02-24
SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction (K162965)Tei Biosciences, Inc.2017-02-16
Miromatrix Biological Mesh TW (K162570)Miromatrix Medical, Inc.2017-02-16
CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) (K162388)Curaseal, Inc.2017-02-03
Endoform Plastics and Reconstructive Matrix (K162461)Aroa Biosurgery (Formerly Mesynthes Limited)2016-12-20
Gentrix Surgical Matrix (K162554)Acell, Inc.2016-10-21
COLORADO THERAPEUTICS XENOGRAFT IMPLANT (K160181)Colorado Therapeutics, LLC2016-10-20
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (K161221)Cook Biotech Incorporated2016-05-26
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft (K160869)Cook Biotech Incorporated2016-04-29
Endoform Reconstructive Template (K153633)Aroa Biosurgery Limited (Formerly Mesynthes Limited)2016-03-15
SurgiPure XD Reconstructive Tissue Matrix (K152206)Tissue Regenix Group Plc2016-03-08
Biodesign Enterocutaneous Fistula Plug (K150668)Cook Biotech Incorprated2015-12-09
SIS Inguinal Hernia Repair Graft (K142887)Cook Biotech Incorprated2015-10-01
LTM-Perforated Surgical Mesh (K150712)Lifecell Corporation2015-07-02
Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix (K141084)Acell, Inc.2015-06-17
HP Tissue Matrix (K142326)Lifecell Corporation2014-12-23
BOVINE PERICARDIUM PATCH (K141721)Collafirm, LLC2014-12-22
OVINE TISSUE MATRIX(OTM) (K141053)TELA Bio, Inc.2014-12-11
FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS (K142070)Rti Surgical, Inc.2014-10-27
CORMATRIX PROTECT ECM ENVELOPE (K140306)Cormatrix Cardiovascular, Inc.2014-08-15
SIS HERNIA GRAFT (K133306)Cook Biotech, Inc.2014-07-23
XENMATRIX SURGICAL GRAFT (K140501)C. R. Bard2014-04-28
MIROMATRIX BIOLOGICAL MESH (K134033)Miromatrix Medical, Inc.2014-03-31
MESO BILAYER SURGICAL MESH (K132025)Kensey Nash Corporation Dba Dsm Biomedical2013-10-30
ENDOFORM RECONSTRUCTIVE TEMPLATE (K130547)Mesynthe, Ltd.2013-05-31
FORTIVA PORCINE DERMIS (K123356)Rti Biologics, Inc.2013-03-05
COLLAGEN TENDON SHEET-D (K122048)Rotation Medical, Inc.2013-01-08
PERMACOL SURGICAL IMPLANT (K120605)Covidien, LLC2012-05-18
COLLAGEN RIBBON (K120019)Wrightmedicaltechnologyinc2012-02-23
SYNERGY TISSUE MATRIX (K113460)Synovis Orthopedic & Woundcare2012-01-11
PROPATCH SOFT TISSUE REPAIR MATRIX (K110581)Cryolife, Inc.2012-01-10
COLLAGEN TENDON SHEET (K112423)Rotation Medical, Inc.2011-12-22
PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF (K112786)Synovis Orthopedic and Woundcare, Inc.2011-10-25
PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX (K111436)Brennen Medical, LLC2011-10-14
XYLOS MACRO-POROUS SURGICAL MESH (K111584)Xylos Corporation2011-08-25
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER (K110402)Cook Biotech, Inc.2011-06-20
MEDEOR MATRIX (K103787)Kensey Nash Corp.2011-02-07
PROPATCH SOFT TISSUE REPAIR MATRIX (K101587)Cryolife, Inc.2010-09-16
KENSEY NASH ECM SURGICAL PATCH (K094061)Kensey Nash Corporation2010-05-18
MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) (K091499)Kensey Nash Corp.2009-10-22
TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 (K091142)Rti Biologics, Inc.2009-08-31
XYLOS POROUS SURGICAL MESH (K090880)Xylos Corporation2009-05-27
MTA PROTECTIVE SHEET (K090778)Xylos Corporation2009-04-28
SECURIAN TISSUE REINFORCEMENT MATRIX (K083823)Xylos Corporation2009-03-18
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG (K082682)Cook Biotech, Inc.2009-02-27
SURGIMEND (K083898)Tei Biosciences, Inc.2009-02-04
VERITAS COLLAGEN MATRIX (DRY) (K083039)Synovis Surgical Innovations2008-11-26
LTM-BPS SURGICAL MESH (K082176)Lifecell Corp.2008-11-14
COLLAMEND FM IMPLANT (K082687)C.R. Bard, Inc.2008-10-17
PORCINE SURGICAL MESH; DERMAL MATRIX (K081272)Brennen Medical, LLC2008-07-31
MODIFICATION TO XYLOS SURGICAL MESH (K081882)Xylos Corporation2008-07-11
TUTOPATCH, TUTOMESH (K081538)Rti Biologics, Inc.2008-06-19
COLLAGEN TENDON WRAP (K080452)Collagen Matrix, Inc.2008-05-15
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 (K073219)American Medical Systems, Inc.2008-04-10
SURGISIS BIODESIGN TISSUE GRAFT (K073391)Cook Biotech, Inc.2008-03-21
LTM-RC SURGICAL MESH (K071986)Lifecell Corp.2007-10-19
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT (K070405)Cook Biotech, Inc.2007-10-17
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT (K071016)DePuy Orthopaedics, Inc.2007-09-04
ORTHOMEND SOFT TISSUE MATRIX (K071807)Tei Biosciences, Inc.2007-08-06
MESOSFOL SURGICAL FILM (K062558)Biomet Manufacturing Corp2007-06-20
LRTM SURGICAL MESH (K070560)Lifecell Corp.2007-06-11
ORTHADAPT BIOIMPLANT (K071065)Pegasus Biologics, Inc.2007-05-04
SIS FACIAL CYLINDER, SIS FACIAL IMPLANT (K070738)Cook Biotech, Inc.2007-04-05
PERIPATCH ENDO-SLEEVE (K063556)Pm Devices, Inc.2007-03-20
VERITAS COLLAGEN MATRIX (K062915)Synovis Surgical Innovations2006-12-06
PROPATCH SOFT TISSUE REPAIR MATRIX (K061892)Cryolife, Inc.2006-11-22
BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 (K063178)C.R. Bard, Inc.2006-11-21
SURGISIS, SURGISIS ES (K062696)Cook Biotech, Inc.2006-10-13
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG (K062729)Cook Biotech, Inc.2006-10-10
SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 (K062320)Cook Biotech, Inc.2006-10-02
ZIMMER COLLAGEN REPAIR PATCH (K053562)Tissue Science Laboratories, Plc2006-06-23
COSMATRIX (K060829)Tei Biosciences, Inc.2006-05-17
XENFORM SOFT TISSUE REPAIR MATRIX (K060984)Tei Biosciences, Inc.2006-05-17
Next →

Track FTM automatically

Every clearance here is in the API, with alerts when new ones post.