FDA 510(k) Applications for Medical Device Product Code "FTL"
(Mesh, Surgical, Polymeric)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K960219 | ADVANCED SURGICAL INNOVATIONS, INC. | PROLEX MESH | 03/15/1996 |
| K061704 | AESCULAP, INC. | OPTILENE MESH | 07/19/2006 |
| K053158 | AESCULAP, INC. | OPTILENE MESH LP | 01/18/2006 |
| K103445 | ALACER BIOMEDICAL INC | ALACER SURGICAL SCAFFOLD | 02/22/2011 |
| K083102 | ALURE MEDICAL INC. | REFINE LIFT SYSTEM | 05/11/2009 |
| K092538 | ALURE MEDICAL INC. | REFINE SUPPORT SYSTEM, MODEL 100.0100 | 03/05/2010 |
| K002721 | AMERICAN MEDICAL SYSTEMS, INC. | AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH | 11/29/2000 |
| K090934 | AMERICAN MEDICAL SYSTEMS, INC. | PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM | 06/02/2009 |
| K070993 | AMERICAN MEDICAL SYSTEMS, INC. | TOPAS SYSTEM | 05/09/2007 |
| K043191 | ANGIOLOGICA B. M. SRL | REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH | 05/16/2005 |
| K050969 | ANULEX TECHNOLOGIES, INC | INCLOSE SURGICAL MESH SYSTEM | 08/18/2005 |
| K093166 | APERTA LLC | WITTMANN PATCH | 12/07/2009 |
| K211132 | Ariste Medical LLC | ARISTE AB Mesh | 03/18/2022 |
| K153632 | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | Endoform Reconstructive Template | 06/16/2016 |
| K181935 | Aroa Biosurgery Ltd. | Endoform Reconstructive Template - Non Absorbable | 12/04/2018 |
| K052830 | ARTIMPLANT AB | SPORTMESH | 01/19/2006 |
| K071887 | ARTIMPLANT AB | SPORTMESH OR ARTELON TISSUE REINFORCEMENT | 09/18/2007 |
| K061445 | ASPIDE MEDICAL | SURGIMESH WN | 02/01/2007 |
| K072974 | ASPIDE MEDICAL | SURGIMESH XB | 08/18/2008 |
| K120025 | ASPIDE MEDICAL | SURGIMESH XB - SKIRTED | 06/26/2012 |
| K092233 | ASPIDE MEDICAL | SURGIMESH XD | 06/25/2010 |
| K100076 | ATRIUM MEDICAL CORP. | ATRIUM C-QUR OVT MESH | 01/26/2010 |
| K002093 | ATRIUM MEDICAL CORP. | ATRIUM LITE MESH | 07/24/2000 |
| K992991 | ATRIUM MEDICAL CORP. | ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT | 01/27/2000 |
| K050311 | ATRIUM MEDICAL CORP. | ATRIUM MEDICAL CORPORATION C-QUR MESH | 03/31/2006 |
| K082748 | ATRIUM MEDICAL CORP. | ATRIUM PROLITE S MESH | 01/14/2009 |
| K070192 | ATRIUM MEDICAL CORP. | ATRIUM PROLITE ULTRA S MESH | 03/08/2007 |
| K080691 | ATRIUM MEDICAL CORP. | C-QUR EDGE MESH V-PATCH | 04/16/2008 |
| K080688 | ATRIUM MEDICAL CORP. | C-QUR LITE MESH V-PATCH | 04/16/2008 |
| K121070 | ATRIUM MEDICAL CORP. | C-QUR RPM MESH | 04/26/2012 |
| K090909 | ATRIUM MEDICAL CORP. | C-QUR V -PATCH MESH | 06/04/2009 |
| K110110 | ATRIUM MEDICAL CORPORATION | ATRIUM CENTRILFX MESH | 02/15/2011 |
| K151386 | ATRIUM MEDICAL CORPORATION | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic | 10/22/2015 |
| K151437 | ATRIUM MEDICAL CORPORATION | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug | 08/27/2015 |
| K113311 | BIOCER ENTWICKLUNGS GMBH | TIO2MESH TM | 07/17/2012 |
| K112567 | BIOMERIX CORPORATION | BIOMERIX ASSURE | 12/23/2011 |
| K112499 | BIOMERIX CORPORATION | BIOMERIX COMPOSITE SURGICAL MESH | 12/23/2011 |
| K082941 | BIOMERIX CORPORATION | BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 | 01/07/2009 |
| K070961 | BIOMERIX CORPORATION | BIOMERIX SURGICAL MESH, MODEL: RCR-01 | 02/25/2008 |
| K093123 | BIOMERIX CORPORATION | BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB | 05/13/2010 |
| K130428 | BIOMUP S.A. | COVAMESH | 10/25/2013 |
| K963226 | BOSTON SCIENTIFIC CORP. | SURGICAL FABRICS | 11/15/1996 |
| K021835 | BRENNEN MEDICAL, INC. | BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX | 10/17/2002 |
| K002351 | BRIDGER BIOMED, INC. | FLUOROTEX II SURGICAL MESH | 08/26/2000 |
| K984197 | BRIDGER BIOMED, INC. | FLUOROTEX SURGICAL MESH | 01/07/1999 |
| K003917 | BRIDGER BIOMED, INC. | MODIFICATION TO FLUOROTEX II SURGICAL MESH | 01/26/2001 |
| K003906 | BRIDGER BIOMED, INC. | MODIFICATION TO FLUROTEX SURGICAL MESH | 01/26/2001 |
| K102766 | C.R. BARD INC | COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM | 12/16/2010 |
| K143743 | C.R. Bard Inc. | ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH | 09/18/2015 |
| K142706 | C.R. Bard Inc. | Modified ONFLEX Mesh | 03/25/2015 |
| K142711 | C.R. Bard Inc. | ONFLEX Mesh | 03/20/2015 |
| K200818 | C.R. Bard, Inc. | 3DMax MID Anatomical Mesh | 07/17/2020 |
| K091659 | C.R. BARD, INC. | BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732 | 08/03/2009 |
| K042026 | C.R. BARD, INC. | BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004 | 09/10/2004 |
| K022350 | C.R. BARD, INC. | BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 | 08/23/2002 |
| K052155 | C.R. BARD, INC. | BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED | 10/20/2005 |
| K033814 | C.R. BARD, INC. | BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007 | 03/01/2004 |
| K132441 | C.R. BARD, INC. | BARD VENTRALEX HERNIA PATCH | 12/13/2013 |
| K021736 | C.R. BARD, INC. | BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 | 07/16/2002 |
| K002684 | C.R. BARD, INC. | COMPOSIX E/X MESH | 10/11/2000 |
| K122436 | C.R. BARD, INC. | COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM | 11/02/2012 |
| K024008 | C.R. BARD, INC. | SMALL BARD VENTRALEX PATCH | 02/20/2003 |
| K153236 | C.R. BARD, INC. | Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay | 05/13/2016 |
| K101928 | C.R. BARD, INC. | VENTRALEX ST HERNIA PATCH | 03/23/2011 |
| K110820 | C.R. BARD, INC. | VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM | 04/01/2011 |
| K130968 | C.R. BARD, INC. | VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM | 05/01/2013 |
| K081777 | C.R. BARD, INC. | VENTRIO HERNIA PATCH | 09/29/2008 |
| K100229 | C.R. BARD, INC. | VENTRIO HERNIA PATCH | 04/21/2010 |
| K113229 | C.R. BARD, INC. | VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING | 07/20/2012 |
| K101920 | C.R. BARD, INC. | VENTRIO ST HERNIA PATCH | 03/23/2011 |
| K101462 | CALDERA MEDICAL, INC. | ASCEND BLUE AC MESH; ASCEND BLUE PC MESH | 08/16/2010 |
| K060004 | CALDERA MEDICAL, INC. | CALDERA MESH | 02/22/2006 |
| K053424 | CALDERA MEDICAL, INC. | POPMESH | 02/22/2006 |
| K023328 | CENTER FOR BIOMATERIALS AND ADVANCED TECHNOLOGIES | REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH | 12/12/2002 |
| K982532 | COGENT | PARIETEX | 01/20/1999 |
| K103568 | COLOPLAST A/S | RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH | 12/22/2010 |
| K111695 | COOK BIOTECH, INC. | HYBRID GRAFT | 04/02/2012 |
| K062697 | COOK BIOTECH, INC. | SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT | 10/13/2006 |
| K070918 | COUSIN BIOTECH | 4DDOME | 08/22/2007 |
| K002479 | COUSIN BIOTECH S.A.R.L | BIOMESH P1 AND BIOMESH PLUG AND PATCH | 10/19/2000 |
| K093196 | COUSIN BIOTECH S.A.S. | BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 | 06/25/2010 |
| K072962 | COUSIN BIOTECH S.A.S. | CABS'AIR | 06/26/2008 |
| K133889 | COUSIN BIOTECH S.A.S. | PREMIUM | 09/04/2014 |
| K220540 | Covidien | ProGrip Self-Gripping Polypropylene Mesh | 09/22/2022 |
| K073164 | COVIDIEN UK MANUFACTURING LTD | IVS TUNNELLER DEVICES | 03/05/2008 |
| K170294 | CR BARD | VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5ö) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4öx 6ö) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6ö) Circle, VENTRALIGHT ST Mesh with ECHO 2 P | 05/01/2017 |
| K182008 | CR Bard Inc. | Phasix ST Mesh with Echo 2 Positioning System | 12/14/2018 |
| K962971 | DAVIS & GECK, INC. | POLYPROPYLENE MESH (VARIOUS SIZES) | 09/16/1996 |
| K081010 | DAVOL INC., SUB. C.R. BARD, INC. | BARD 3DMAX MESH | 10/07/2008 |
| K061754 | DAVOL INC., SUB. C.R. BARD, INC. | BARD COMPOSITE L/P MESH | 10/23/2006 |
| K061314 | DAVOL INC., SUB. C.R. BARD, INC. | BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH | 06/02/2006 |
| K092032 | DAVOL INC., SUB. C.R. BARD, INC. | BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 | 12/08/2009 |
| K101851 | DAVOL INC., SUB. C.R. BARD, INC. | VENTRALIGHT ST MESH | 07/15/2010 |
| K003323 | DAVOL, INC. | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 | 01/22/2001 |
| K971745 | DAVOL, INC., SUB. C.R. BARD, INC. | BARD COMPOSITE PROSTHESIS | 08/06/1997 |
| K991637 | DAVOL, INC., SUB. C.R. BARD, INC. | BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 | 06/22/1999 |
| K193144 | Deep Blue Medical Advances, Inc. | T-Line Hernia Mesh | 03/30/2020 |
| K221556 | Deep Blue Medical Advances, Inc. | T-Line Hernia Mesh | 11/28/2022 |
| K230227 | Deep Blue Medical Advances, Inc. | T-Line Hernia Mesh | 02/23/2023 |
| K963141 | DOUGLAS BUESCHEL | KUGEL HERNIA PATCH | 10/11/1996 |
| K150906 | EHICON INC. | ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh | 07/24/2015 |
| K060329 | ENDOGUN MEDICAL SYSTEMS | ENDOFAST RELIANT SYSTEM | 09/11/2006 |
| K080836 | ENDOGUN MEDICAL SYSTEMS | MODIFICATION TO ENDOFAST RELIANT SYSTEM | 04/21/2008 |
| K093932 | ETHICON GMBH | ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH | 04/09/2010 |
| K180910 | Ethicon Inc | ULTRAPRO Mesh and ULTRAPRO ADVANCED | 07/02/2018 |
| K060713 | ETHICON INC. | PROCEED SURGICAL MESH | 05/25/2006 |
| K082216 | ETHICON INC. | TBD ETHICON MESH | 09/05/2008 |
| K180829 | Ethicon, Inc | PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh | 06/28/2018 |
| K141560 | ETHICON, INC. | ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE | 10/23/2014 |
| K984220 | ETHICON, INC. | MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH | 02/23/1999 |
| K031925 | ETHICON, INC. | PROCEED TRILAMINATE SURGICAL MESH | 09/17/2003 |
| K061533 | ETHICON, INC. | PROCEED VENTRAL PATCH | 12/11/2006 |
| K181268 | Ethicon, Inc. | PROLENE (Polypropylene) 3D Patch | 07/26/2018 |
| K010722 | ETHICON, INC. | PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH | 04/27/2001 |
| K972412 | ETHICON, INC. | PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH | 09/10/1997 |
| K962530 | ETHICON, INC. | PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH | 08/09/1996 |
| K001122 | ETHICON, INC. | PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH | 05/23/2000 |
| K163152 | Ethicon, Inc. | PROLENE Soft Polypropylene Mesh | 03/11/2017 |
| K172089 | Ethicon, Inc. | PROLENE Soft Polypropylene Mesh | 10/05/2017 |
| K133198 | ETHICON, INC. | ULTRAPRO COMFORT PLUG | 05/30/2014 |
| K033337 | ETHICON, INC. | ULTRAPRO MESH | 04/01/2004 |
| K070224 | ETHICON, INC. | ULTRAPRO PLUG | 04/17/2007 |
| K071249 | ETHICON, INC. | ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV | 06/05/2007 |
| K051701 | ETHICON, INC. | VICRYL * MESH BAG | 09/29/2005 |
| K191373 | Ethicon, Inc. | VICRYL Mesh | 10/22/2019 |
| K201143 | Ethicon, Inc. | VICRYL Mesh | 08/06/2020 |
| K002672 | ETHICON, INC. | VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH | 11/22/2000 |
| K063154 | EVERA MEDICAL, INC. | FACIAL RECONSTRUCTIVE MESH (FRM) | 07/10/2007 |
| K191545 | Exogenesis Corporation | Exogenesis Hernia Mesh | 09/26/2019 |
| K182087 | FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft | DynaMesh-POSTERIOR | 10/31/2018 |
| K131530 | FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL | DYNAMESH -CICAT | 10/23/2013 |
| K073579 | FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL | DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN | 08/18/2008 |
| K161550 | FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESELLSCHAFT | DynaMesh-VENTRAL | 12/22/2016 |
| K964857 | FUSION MEDICAL TECHNOLOGIES, INC. | RAPISEAL PATCH | 02/18/1997 |
| K961440 | FUSION MEDICAL TECHNOLOGIES, INC. | SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH | 05/31/1996 |
| K070018 | GENERIC MEDICAL DEVICE, INC. | UNIVERSAL SURGICAL MESH, MODEL 100 | 04/27/2007 |
| K994328 | GENZYME CORP. | SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX | 03/02/2000 |
| K053066 | GENZYME CORPORATION | SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH | 12/19/2005 |
| K063739 | GENZYME CORPORATION | SEPRAMESH, MODEL 5959-1214 | 01/17/2007 |
| K031225 | GFE MEDIZINTECHNIK GMBH | TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 | 09/29/2003 |
| K954665 | GLYCAR, INC. | GLYCAR STAPLE STRIPS | 02/14/1996 |
| K973955 | HERNIAMESH | HERNIAMESH SURGICAL MESHES | 05/11/1998 |
| K081327 | HERNIAMESH S.R.L. | RELIMESH | 06/19/2008 |
| K170134 | IconLab Inc. | Reperen Surgical Mesh | 08/09/2017 |
| K071470 | IMPLANTECH ASSOCIATES INC. | IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX | 08/31/2007 |
| K010533 | INJECTX, INC. | BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH | 05/24/2001 |
| K113552 | Insightra Medical | FREEDOM INGUINAL HERNIA IMPLANT | 08/23/2012 |
| K140967 | Insightra Medical | FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK | 06/10/2014 |
| K142192 | Insightra Medical | Insightra Freedom Ventral Hernia Repair System | 05/07/2015 |
| K192112 | International Life Sciences | FlexBand Plus | 09/27/2019 |
| K014183 | J&J CORPORATE BIOMATERIALS CENTER | AFB (ABSORBABLE FOAM BUTTRESS) | 06/12/2002 |
| K090489 | KCI USA, INC. | ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 | 05/14/2009 |
| K071695 | KENSEY NASH CORP. | KENSEY NASH MACROPORE SHIELD | 12/31/2007 |
| K022011 | KINETIC CONCEPTS, INC. | V.A.C. ABDOMINAL DRESSING | 02/26/2003 |
| K080353 | LIFECELL CORP. | LTM-T SURGICAL MESH | 04/03/2008 |
| K181094 | lntegra LifeSciences | Polydioxanone Surgical Scaffold | 08/02/2018 |
| K031955 | MACROPORE BIOSURGERY, INC. | MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET | 09/22/2003 |
| K012025 | MACROPORE BIOSURGERY, INC. | MACROPORE SURGIWRAP (TS) | 12/03/2001 |
| K070625 | MARKETING SOLUTIONS INC. | PELVIMESH / HERMESH 7 | 08/01/2007 |
| K072190 | MAST BIOSURGERY | ORTHO-WRAP BIORESORBABLE SHEET | 01/16/2008 |
| K200918 | MAST Biosurgery | SurgiWrap FROST | 01/07/2021 |
| K050332 | MAST BIOSURGERY USA INC. | SURGI-WRAP MAST BIORESORBABLE SHEET | 05/27/2005 |
| K061473 | MAST BIOSURGERY USA INC. | SURGI-WRAP MAST BIORESORBABLE SHEET | 09/21/2006 |
| K063648 | MAST BIOSURGERY USA INC. | SURGI-WRAP MAST TENDON SHEET | 03/07/2007 |
| K002699 | MEDICAL DEVICE CONSULTANTS, INC. | PARIETEX COMPOSITE (PCO) MESH | 02/15/2001 |
| K120844 | MEDLINX ACALA PTE LTD | MEDLINX SURGICAL MESH | 12/13/2012 |
| K142611 | MEDTRONIC TYRX, INC. | TYRX Neuro Absorbable Antibacterial Envelope | 12/31/2014 |
| K150291 | MEDTRONIC TYRX, INC. | TYRX Neuro Absorbable Antibacterial Envelope | 03/27/2015 |
| K180030 | Medtronic, Inc. | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | 04/24/2018 |
| K192389 | Medtronic, Inc. | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | 03/27/2020 |
| K192636 | Medtronic, Inc. | TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) | 04/08/2020 |
| K180122 | Medtronic, Inc. | TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) | 06/07/2018 |
| K980483 | MENTOR CORP. | MENTOR SUSPEND SLING | 04/30/1998 |
| K100313 | MIMEDX GROUP, INC | HYDROFIX SURGICAL SHEET | 06/14/2011 |
| K080393 | MINNESOTA MEDICAL DEVELOPMENT, INC. | MODIFICATION TO REBOUND HRD | 03/13/2008 |
| K063671 | MINNESOTA MEDICAL DEVELOPMENT, INC. | REBOUND HRD | 08/16/2007 |
| K083467 | MINNESOTA MEDICAL DEVELOPMENT, INC. | REBOUND HRDV | 04/23/2009 |
| K092224 | NOVUS SCIENTIFIC PTE LTD | TIGR SURGICAL MESH , MODEL WK-6 | 01/25/2010 |
| K081377 | NUVASIVE, INC. | NUVASIVE SURGICAL MESH SYSTEM | 01/15/2009 |
| K053215 | NUVASIVE, INC. | SURGICAL MESH SYSTEM | 07/17/2006 |
| K970561 | ORGANOGENESIS, INC. | GRAFT PATCH | 08/01/1997 |
| K032673 | OSTEOBIOLOGICS, INC. | IMMIX PLASTIFILM | 10/02/2003 |
| K024199 | OSTEOBIOLOGICS, INC. | IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP | 03/14/2003 |
| K983753 | OSTEOGENICS, INC. | STAR TEMPORARY WOUND COVER | 11/18/1999 |
| K061934 | OSTEOGENICS, INC. | XTAC | 07/17/2007 |
| K090288 | PEGASUS BIOLOGICS, INC. | ORTHADAPT PR | 05/05/2009 |
| K042811 | Polyganics BV | VIVOSORB SHEET, MODEL FS01 | 11/08/2004 |
| K090271 | PROMETHEAN SURGICAL DEVICES, INC. | HYDROCOAT MESH | 01/14/2010 |
| K070846 | PROSURG, INC. | MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM | 07/02/2007 |
| K030631 | PROSURG, INC. | ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH | 05/19/2003 |
| K052100 | PROXY BIOMEDICAL LTD. | MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH | 08/11/2005 |
| K050678 | PROXY BIOMEDICAL LTD. | MOTIFMESH SOFT TISSUE PATCH | 05/20/2005 |
| K111121 | PROXY BIOMEDICAL LTD. | VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH | 05/13/2011 |
| K172636 | Proxy Biomedical Ltd. | VitaMESH Macroporous PP Surgical Mesh | 04/30/2018 |
| K060520 | PROXY BIOMEDICAL LTD. | VITAMESH MACROPOROUS PP SURGICAL MESH | 03/28/2006 |
| K080216 | S. JACKSON, INC. | SUPRAMESH EXTRA | 09/15/2008 |
| K990930 | SANTERRA MEDICAL TECHNOLOGY, INC. | 3D ANATOMICAL MESH | 06/17/1999 |
| K974540 | SENTRON MEDICAL, INC. | SIS HERNIA REPAIR DEVICE | 05/20/1998 |
| K080442 | SERICA TECHNOLOGIES, INC. | SERISCAFFOLD SURGICAL MESH | 11/13/2008 |
| K032893 | SHELHIGH, INC. | SHELHIGH NO-REACT BIOCUFF | 12/19/2003 |
| K981756 | SHELHIGH, INC. | SHELHIGH NO-REACT PNEUMOPLEDGETS | 08/05/1998 |
| K112784 | SMITH & NEPHEW, INC. | RENASYS AB ABOMINAL DRESSING KIT | 11/22/2011 |
| K100787 | SMITH & NEPHEW, INC. | RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT | 09/17/2010 |
| K192443 | Sofradim Production | Dextile Anatomical Mesh | 12/06/2019 |
| K172395 | Sofradim Production | Duatene bilayer mesh | 02/01/2018 |
| K040998 | SOFRADIM PRODUCTION | MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH | 04/29/2004 |
| K110663 | SOFRADIM PRODUCTION | PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES) | 08/11/2011 |
| K101197 | SOFRADIM PRODUCTION | PARIE TENE PROGRIP MESH | 05/05/2010 |
| K163212 | Sofradim Production | Parietene DS Composite Mesh | 06/29/2017 |
| K223218 | Sofradim Production | Parietene Macroporous Mesh | 12/02/2022 |
| K142091 | SOFRADIM PRODUCTION | PARIETENE MACROPOROUS MESH | 10/17/2014 |
| K991400 | SOFRADIM PRODUCTION | PARIETENE POLYPROPYLENE MESH | 07/12/1999 |
| K081126 | SOFRADIM PRODUCTION | PARIETEX COMPOSITE MONO PM MESH | 08/13/2008 |
| K050187 | SOFRADIM PRODUCTION | PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES | 02/18/2005 |
| K120506 | SOFRADIM PRODUCTION | PARIETEX COMPOSITE VENTRAL PATCH | 06/13/2012 |
| K090858 | SOFRADIM PRODUCTION | PARIETEX MONOFILAMENT POLYESTER MESH | 05/06/2009 |
| K142908 | SOFRADIM PRODUCTION | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh | 11/14/2014 |
| K110816 | SOFRADIM PRODUCTION | PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES) | 04/19/2011 |
| K110815 | SOFRADIM PRODUCTION | PARIETEX OPTIMIZED COMPOSTIE MESH | 04/19/2011 |
| K101519 | SOFRADIM PRODUCTION | PARIETEX PLUG AND PATCH | 11/05/2010 |
| K071629 | SOFRADIM PRODUCTION | PARIETEX POLYESTER MESH WITH INTRODUCER | 07/10/2007 |
| K103682 | SOFRADIM PRODUCTION | PARIETEX PROGRIP | 03/04/2011 |
| K081050 | SOFRADIM PRODUCTION | PARIETEX PROGRIP MESH | 05/28/2008 |
| K142900 | SOFRADIM PRODUCTION | Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh | 10/28/2014 |
| K173796 | Sofradim Production | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) | 03/09/2018 |
| K073287 | SOFRADIM PRODUCTION | PREVADH MESH | 03/13/2008 |
| K143386 | SOFRADIM PRODUCTION | Progrip Laparoscopic Self-Fixating Mesh | 03/13/2015 |
| K123479 | SOFRADIM PRODUCTION | PROGRIP LAPAROSCOPIC SELF-FIXATING MESH | 12/11/2012 |
| K120897 | SOFRADIM PRODUCTION | PROGRIP LAPARSCOPIC SELF-FIXATING MESH | 06/29/2012 |
| K140941 | SOFRADIM PRODUCTION | PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH | 05/07/2014 |
| K003990 | SOFRADIM PRODUCTION | SOFRADIM PARIETEX SURGICAL MESHES | 01/24/2001 |
| K220586 | Sofradim Production | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | 06/22/2022 |
| K131969 | SOFRADIM PRODUCTION | SYMBOTEX(TM) COMPOSITE MESH | 08/22/2013 |
| K033376 | SOFRADIM PRODUCTION | UGYTEX MESH | 01/15/2004 |
| K150091 | SOFRADIM PRODUCTION | Versatex Monofilament Mesh | 05/26/2015 |
| K973082 | SPECIALTY SURGICAL PRODUCTS, INC. | VENTRAL WALL DEFECT REDUCTION SILO | 11/04/1997 |
| K072370 | SURGICRAFT LTD. | SURGICRAFT SURGICAL MESH SYSTEM | 07/24/2008 |
| K060018 | SUTURES INDIA PVT., LTD. | TRULENE MESH | 07/26/2006 |
| K141394 | SYNTHASOME | X-REPAIR | 08/06/2014 |
| K083307 | SYNTHASOME, INC. | SYNTHASOME X-REPAIR | 03/27/2009 |
| K141499 | SYNTHASOME, INC. | X-REPAIRSL | 07/02/2014 |
| K971472 | TECHNICAL PRODUCTS, INC. | SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA | 07/01/1997 |
| K031188 | TEI BIOSCIENCES INC. | ORTHOMEND | 06/27/2003 |
| K051766 | TEI BIOSCIENCES INC. | ORTHOMEND | 08/11/2005 |
| K072520 | TEPHA, INC. | TEPHAFLEX SURGICAL FILM | 11/29/2007 |
| K050418 | TFS MANUFACTURING PTY LTD | TISSUE FIXATION SYSTEM | 05/16/2005 |
| K992556 | TISSUE SCIENCE LABORATORIES, PLC | PERMACOL | 02/17/2000 |
| K043366 | TISSUE SCIENCE LABORATORIES, PLC | PERMACOL SURGICAL IMPLANT | 12/17/2004 |
| K960481 | TISSUE TECHNOLOGIES, INC. | SOFT TISSUE AUGMENTATION TUBE | 04/01/1996 |
| K962496 | TISSUE TECHNOLOGIES, INC. | SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.) | 09/03/1996 |
| K982475 | TISSUE TECHNOLOGIES, INC. | SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL | 09/22/1998 |
| K000849 | TISSUE TECHNOLOGIES, INC. | SOFTFORM FACIAL IMPLANT | 05/19/2000 |
| K973462 | TISSUE TECHNOLOGIES, INC. | SOFTFORM FACIAL IMPLANT | 11/24/1997 |
| K002071 | TISSUE TECHNOLOGIES, INC. | SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES | 07/24/2000 |
| K102788 | TORNIER, INC. | TORNIER BIOFIBER SCAFFOLD | 05/10/2011 |
| K111337 | TORNIER, INC. | TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD | 01/25/2012 |
| K093799 | TORNIER, INC. | TORNIER SURGICAL MESH | 04/22/2010 |
| K132699 | TYRX , INC. | AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) | 11/26/2013 |
| K130943 | TYRX , INC. | AIGIS RX R PM/ AIGIS RX R ICD | 05/20/2013 |
| K131007 | TYRX ,INC | AIGIS RX N MEDIUM; AIGIS RX N LARGE | 07/10/2013 |
| K093524 | TYRX ,INC | PIVIT A/B ST AND PIVIT A/B ST-R | 03/26/2010 |
| K053656 | TYRX PHARMA INC | TYRX ANTIMICROBIAL MESH | 07/14/2006 |
| K052864 | TYRX PHARMA INC | TYRX SURGICAL MESH, MODEL SMPC-0501 | 12/22/2005 |
| K063091 | TYRX PHARMA, INC. | PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 | 01/16/2008 |
| K152678 | TYRX, INC. | TYRX Neuro Antibacterial Envelope | 11/17/2015 |
| K010035 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | IVS TUNNELLER | 04/04/2001 |
| K982575 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | MESH, SURGICAL, POLYMERIC | 11/06/1998 |
| K070644 | W. L. GORE & ASSOCIATES, INC. | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS | 04/02/2007 |
| K063435 | W. L. GORE & ASSOCIATES, INC. | GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL | 11/28/2006 |
| K043081 | W. L. GORE & ASSOCIATES, INC. | GORE POLYPROPYLENE HERNIA MESH | 12/22/2004 |
| K032865 | W. L. GORE & ASSOCIATES, INC. | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | 11/28/2003 |
| K163576 | W. L. Gore & Associates, Inc. | GORE SYNECOR Preperitoneal Biomaterial | 05/11/2017 |
| K032168 | W. L. GORE & ASSOCIATES, INC. | GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL | 08/15/2003 |
| K152609 | W.L GORE & ASSOCIATES, INC. | GORE SYNECOR Biomaterial | 12/11/2015 |
| K053202 | W.L. GORE & ASSOCIATES | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | 12/07/2005 |
| K022782 | W.L. GORE & ASSOCIATES,INC | DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL | 09/10/2002 |
| K083266 | W.L. GORE & ASSOCIATES,INC | GORE BIO-A FISTULA PLUG | 03/27/2009 |
| K081069 | W.L. GORE & ASSOCIATES,INC | GORE INFINIT MESH | 05/30/2008 |
| K043056 | W.L. GORE & ASSOCIATES,INC | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | 12/22/2004 |
| K053200 | W.L. GORE & ASSOCIATES,INC | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | 12/07/2005 |
| K992189 | W.L. GORE & ASSOCIATES,INC | GORE-TEX DUALMESH BIOMATERIAL | 07/29/1999 |
| K955494 | W.L. GORE & ASSOCIATES,INC | GORE-TEX DUALMESH BIOMATERIAL WITH HOLES | 01/24/1996 |
| K000185 | W.L. GORE & ASSOCIATES,INC | GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM) | 02/14/2000 |
| K010228 | W.L. GORE & ASSOCIATES,INC | GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES | 02/21/2001 |
| K962401 | W.L. GORE & ASSOCIATES,INC | GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES | 09/03/1996 |
| K965038 | W.L. GORE & ASSOCIATES,INC | GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE | 02/06/1997 |
| K963619 | W.L. GORE & ASSOCIATES,INC | GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES | 10/25/1996 |
| K964761 | W.L. GORE & ASSOCIATES,INC | S.A.M. FACIAL IMPLANT W/INTRODUCER | 01/27/1997 |
| K981051 | W.L. GORE & ASSOCIATES,INC | SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES | 04/15/1998 |
| K230671 | Xiros Ltd | Pitch PaSoft Tissue Reinforcement Device | 05/31/2023 |
| K211563 | Xiros Ltd | Pitch-Patchs | 08/13/2021 |
| K220091 | Xiros Ltd | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | 08/26/2022 |
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