FDA 510(k) Applications for Medical Device Product Code "FTM"
(Mesh, Surgical)

FDA 510(k) Number Applicant Device Name Decision Date
K040621 ACELL, INC ACELL UBM SURGICAL MESH 04/14/2004
K041140 ACELL, INC ACELL UBM SURGICAL MESH ML AND MLPLUS 07/07/2004
K141084 ACELL, INC Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix 06/17/2015
K162554 Acell, Inc. Gentrix Surgical Matrix 10/21/2016
K170763 ACell, Inc. Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend 06/08/2017
K182259 ACell, Inc. Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal 02/07/2019
K203600 Alafair Biosciences Inc VersaWrap 03/09/2021
K213163 Alafair Biosciences Inc VersaWrap 10/29/2021
K200311 Alafair Biosciences Inc VersaWrap Tendon Protector 03/06/2020
K073219 AMERICAN MEDICAL SYSTEMS, INC. WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 04/10/2008
K162461 AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED) Endoform Plastics and Reconstructive Matrix 12/20/2016
K153633 Aroa Biosurgery Limited (Formerly Mesynthes Limited) Endoform Reconstructive Template 03/15/2016
K183398 Aroa Biosurgery Ltd. Endoform Restella 04/11/2019
K173242 Aziyo Biologics, Inc. CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) 10/25/2017
K201313 Aziyo Biologics, Inc. CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) 06/15/2020
K192616 Aziyo Biologics, Inc. CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) 10/21/2019
K182255 Aziyo Biologics, Inc. CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) 11/15/2018
K192452 B. Bruan Surgical, SA Lyograft 09/03/2020
K961811 BIO-VASCULAR, INC. PERI-GUARD PERICARDIUM 06/13/1996
K983162 BIO-VASCULAR, INC. PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC 10/09/1998
K971048 BIO-VASCULAR, INC. PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT 05/09/1997
K992537 BIO-VASCULAR, INC. PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED 02/22/2000
K961810 BIO-VASCULAR, INC. SUPPLE PERI-GUARD PERICARDIUM 06/13/1996
K062558 BIOMET MANUFACTURING CORP. MESOSFOL SURGICAL FILM 06/20/2007
K111436 BRENNEN MEDICAL, LLC PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX 10/14/2011
K081272 BRENNEN MEDICAL, LLC PORCINE SURGICAL MESH; DERMAL MATRIX 07/31/2008
K140501 C.R. BARD XENMATRIX SURGICAL GRAFT 04/28/2014
K052322 C.R. BARD, INC. BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105 04/10/2006
K063178 C.R. BARD, INC. BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 11/21/2006
K031332 C.R. BARD, INC. BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH 05/15/2003
K082687 C.R. BARD, INC. COLLAMEND FM IMPLANT 10/17/2008
K021160 CARBON MEDICAL TECHNOLOGIES, INC. DERMMATRIX SURGICAL MESH 06/12/2002
K141721 COLLAFIRM LLC BOVINE PERICARDIUM PATCH 12/22/2014
K080452 COLLAGEN MATRIX, INC. COLLAGEN TENDON WRAP 05/15/2008
K160181 Colorado Therapeutics LLC COLORADO THERAPEUTICS XENOGRAFT IMPLANT 10/20/2016
K172937 Colorado Therapeutics LLC Colorado Therapeutics Xenograft Implant 10/25/2017
K171817 Cook Biotech Incorporated Biodesign Diaphragmatic Hernia Graft 03/13/2018
K170016 Cook Biotech Incorporated Biodesign Fistula Plug 06/21/2017
K162934 Cook Biotech Incorporated Biodesign Parastomal Hernia Repair Graft 07/10/2017
K161221 Cook Biotech Incorporated Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug 05/26/2016
K201000 Cook Biotech Incorporated Biodesign Staple Line Reinforcement 07/13/2020
K160869 COOK BIOTECH INCORPORATED Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft 04/29/2016
K150668 COOK BIOTECH INCORPRATED Biodesign Enterocutaneous Fistula Plug 12/09/2015
K142887 COOK BIOTECH INCORPRATED SIS Inguinal Hernia Repair Graft 10/01/2015
K110402 COOK BIOTECH, INC. BIODESIGN NIPPLE RECONSTRUCTION CYLINDER 06/20/2011
K070405 COOK BIOTECH, INC. MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT 10/17/2007
K050246 COOK BIOTECH, INC. SIS DERMAL AUGMENTATION STRAND 05/19/2005
K070738 COOK BIOTECH, INC. SIS FACIAL CYLINDER, SIS FACIAL IMPLANT 04/05/2007
K050337 COOK BIOTECH, INC. SIS FISTULA PLUG 03/09/2005
K133306 COOK BIOTECH, INC. SIS HERNIA GRAFT 07/23/2014
K034039 COOK BIOTECH, INC. SIS PLASTIC SURGERY MATRIX 02/18/2004
K980431 COOK BIOTECH, INC. SURGISIS 05/28/1998
K082682 COOK BIOTECH, INC. SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG 02/27/2009
K073391 COOK BIOTECH, INC. SURGISIS BIODESIGN TISSUE GRAFT 03/21/2008
K062320 COOK BIOTECH, INC. SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 10/02/2006
K062729 COOK BIOTECH, INC. SURGISIS RVP RECTO-VAGINAL FISTULA PLUG 10/10/2006
K051048 COOK BIOTECH, INC. SURGISIS STAPLE LINE REINFORCEMENT II 09/23/2005
K062696 COOK BIOTECH, INC. SURGISIS, SURGISIS ES 10/13/2006
K140306 CORMATRIX CARDIOVASCULAR, INC. CORMATRIX PROTECT ECM ENVELOPE 08/15/2014
K120605 Covidien LLC PERMACOL SURGICAL IMPLANT 05/18/2012
K061892 CRYOLIFE, INC. PROPATCH SOFT TISSUE REPAIR MATRIX 11/22/2006
K101587 CRYOLIFE, INC. PROPATCH SOFT TISSUE REPAIR MATRIX 09/16/2010
K110581 CRYOLIFE, INC. PROPATCH SOFT TISSUE REPAIR MATRIX 01/10/2012
K162388 CURASEAL, INC. CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) 02/03/2017
K031969 DEPUY ORTHOPAEDICS, INC. DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT 07/28/2003
K071016 DEPUY ORTHOPAEDICS, INC. DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT 09/04/2007
K001738 DEPUY ORTHOPAEDICS, INC. DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT 12/27/2000
K982330 DEPUY, INC. DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT 09/25/1998
K203496 Geistlich Pharma AG Nexo-Gide Bilayer Collagen Membrane 07/14/2021
K040868 GENZYME CORP. SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH 06/04/2004
K963175 GLYCAR, INC. GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING 09/23/1996
K040756 IMPLEX CORP. THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX 07/14/2004
K053655 INTEGRA LIFESCIENCES CORPORATION TENDON WRAP TENDON PROTECTOR 02/03/2006
K041923 KENSEY NASH CORP. BIOBLANKET 09/08/2004
K043259 KENSEY NASH CORP. BIOBLANKET SURGICAL MESH 08/15/2005
K103787 KENSEY NASH CORP. MEDEOR MATRIX 02/07/2011
K091499 KENSEY NASH CORP. MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) 10/22/2009
K061030 KENSEY NASH CORPORATION BIOBLANKET SURGICAL MESH 05/09/2006
K094061 KENSEY NASH CORPORATION KENSEY NASH ECM SURGICAL PATCH 05/18/2010
K132025 KENSEY NASH CORPORATION DBA DSM BIOMEDICAL MESO BILAYER SURGICAL MESH 10/30/2013
K070560 LIFECELL CORP. LRTM SURGICAL MESH 06/11/2007
K082176 LIFECELL CORP. LTM-BPS SURGICAL MESH 11/14/2008
K071986 LIFECELL CORP. LTM-RC SURGICAL MESH 10/19/2007
K162752 LIFECELL CORPORATION ARTIA Reconstructive Tissue Matrix Perforated 02/24/2017
K142326 LifeCell Corporation HP Tissue Matrix 12/23/2014
K150712 LifeCell Corporation LTM-Perforated Surgical Mesh 07/02/2015
K130547 MESYNTHE LTD ENDOFORM RECONSTRUCTIVE TEMPLATE 05/31/2013
K134033 MIROMATRIX MEDICAL INC. MIROMATRIX BIOLOGICAL MESH 03/31/2014
K162570 Miromatrix Medical Inc. Miromatrix Biological Mesh TW 02/16/2017
K042809 ORGANOGENESIS, INC. CUFFPATCH 11/02/2004
K011025 ORGANOGENESIS, INC. FORTAFLEX SURGICAL MESH 08/24/2001
K020049 ORGANOGENESIS, INC. FORTAFLEX SURGICAL MESH 03/18/2002
K021105 ORGANOGENESIS, INC. FORTAFLEX SURGICAL MESH 05/10/2002
K011027 ORGANOGENESIS, INC. FORTAFLEX SURGICAL SLING 05/30/2001
K021107 ORGANOGENESIS, INC. FORTAFLEX SURGICAL SLING 05/15/2002
K071065 PEGASUS BIOLOGICS, INC. ORTHADAPT BIOIMPLANT 05/04/2007
K043388 PEGASUS BIOLOGICS, INC. PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH 08/05/2005
K063556 PM DEVICES, INC. PERIPATCH ENDO-SLEEVE 03/20/2007
K040835 PM DEVICES, INC. PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16 06/15/2004
K033985 PM DEVICES, INC. PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10 06/04/2004
K040364 POREX SURGICAL, INC. MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH 06/30/2004
K112423 ROTATION MEDICAL, INC. COLLAGEN TENDON SHEET 12/22/2011
K122048 ROTATION MEDICAL, INC. COLLAGEN TENDON SHEET-D 01/08/2013
K123356 RTI BIOLOGICS, INC. FORTIVA PORCINE DERMIS 03/05/2013
K081538 RTI BIOLOGICS, INC. TUTOPATCH, TUTOMESH 06/19/2008
K091142 RTI BIOLOGICS, INC. TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 08/31/2009
K142070 RTI SURGICAL, INC. FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS 10/27/2014
K973379 S. JACKSON, INC. STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS 09/25/1997
K991567 SHELHIGH, INC. SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. 07/14/1999
K223052 Synovis Life Technologies, Inc. Peri-Guard and Supple Peri-Guard 04/07/2023
K192615 Synovis Life Technologies, Inc. (Baxter International Inc.) Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) 12/17/2019
K213125 Synovis Life Technologies. Inc. (A Subsidiary Of Baxter PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology 10/27/2021
K113460 SYNOVIS ORTHOPEDIC & WOUNDCARE SYNERGY TISSUE MATRIX 01/11/2012
K112786 SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC. PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF 10/25/2011
K040119 SYNOVIS SURGICAL INNOVATIONS PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION 03/17/2004
K062915 SYNOVIS SURGICAL INNOVATIONS VERITAS COLLAGEN MATRIX 12/06/2006
K083039 SYNOVIS SURGICAL INNOVATIONS VERITAS COLLAGEN MATRIX (DRY) 11/26/2008
K041669 SYNOVIS SURGICAL INNOVATIONS VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD 10/27/2004
K051879 SYNTHES (USA) SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS 10/05/2005
K183472 Synthes (USA) Products LLC DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio û MR Conditional 03/13/2019
K060829 TEI BIOSCIENCES INC. COSMATRIX 05/17/2006
K071807 TEI BIOSCIENCES INC. ORTHOMEND SOFT TISSUE MATRIX 08/06/2007
K083898 TEI BIOSCIENCES INC. SURGIMEND 02/04/2009
K162965 TEI Biosciences Inc. SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction 02/16/2017
K020455 TEI BIOSCIENCES INC. TISSUEMEND SOFT TISSUE REPAIR MATRIX 04/03/2002
K060989 TEI BIOSCIENCES INC. TISSUEMEND SOFT TISSUE REPAIR MATRIX 05/15/2006
K060984 TEI BIOSCIENCES INC. XENFORM SOFT TISSUE REPAIR MATRIX 05/17/2006
K214070 TELA Bio OviTex PRS (Long Term Resorbable) 03/21/2023
K141053 TELA BIO, INC. OVINE TISSUE MATRIX(OTM) 12/11/2014
K182493 Tisgenx Bovine Pericardial Tissue Patch 06/18/2019
K152206 TISSUE REGENIX GROUP PLC SurgiPure XD Reconstructive Tissue Matrix 03/08/2016
K013625 TISSUE SCIENCE LABORATORIES, PLC PERMACOL 01/17/2002
K021056 TISSUE SCIENCE LABORATORIES, PLC PERMACOL 10/31/2002
K053562 TISSUE SCIENCE LABORATORIES, PLC ZIMMER COLLAGEN REPAIR PATCH 06/23/2006
K991296 TUTOGEN MEDICAL U.S., INC. TUTOPATCH 10/06/2000
K030782 W. L. GORE & ASSOCIATES, INC. SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL 04/21/2003
K120019 WRIGHT MEDICAL TECHNOLOGY, INC. COLLAGEN RIBBON 02/23/2012
K081882 XYLOS CORPORATION MODIFICATION TO XYLOS SURGICAL MESH 07/11/2008
K090778 XYLOS CORPORATION MTA PROTECTIVE SHEET 04/28/2009
K083823 XYLOS CORPORATION SECURIAN TISSUE REINFORCEMENT MATRIX 03/18/2009
K111584 XYLOS CORPORATION XYLOS MACRO-POROUS SURGICAL MESH 08/25/2011
K090880 XYLOS CORPORATION XYLOS POROUS SURGICAL MESH 05/27/2009
K023237 XYLOS CORPORATION XYLOS SURGICAL MESH 03/18/2003


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