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 |