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
K944413 AMERICAN CUSTOM MEDICAL, INC. ACM PTFE SURGICAL MESH 11/09/1994
K840172 AMERICAN HEYER SCHULTE VENTRAL WALL DEFECT REDUCT SILO 06/27/1984
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
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
K930669 ATRIUM MEDICAL CORP. ATRIUM POLYPROPYLENE MESH 12/16/1993
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
K942583 BIO-VASCULAR, INC. PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT 07/08/1994
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
K933827 BIOPLEXUS CORP. BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS 06/30/1994
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
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
K922916 C.R. BARD, INC. BARD MARLEX MESH DART 08/24/1992
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
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
K792281 DAVOL, INC. USHER'S MARLEX TUBULAR MESH 11/27/1979
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
K953577 DAVOL, INC., SUB. C.R. BARD, INC. BARD VISILEX MESH 3" X 6" 09/26/1995
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
K810428 ETHICON, INC. VICRYL 03/13/1981
K051701 ETHICON, INC. VICRYL * MESH BAG 09/29/2005
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
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
K941299 FLARED PATCH, INC. FLARED PATCH 08/23/1994
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
K945060 GERARD MEDICAL, INC. HERNIA MESH INTRODUCTION SYSTEM 03/02/1995
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
K942911 GLYCAR, INC. GLYCAR TISSUE REPAIR PATCH 12/14/1994
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
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
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
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
K924749 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. TRELEX MESH 11/23/1992
K945377 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. TRELEX NATURAL(R) MESH 12/08/1994
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
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
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
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
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
K181094 Surgical Innovation Associates, Inc. Polydioxanone Surgical Scaffold 08/02/2018
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
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K982475 TISSUE TECHNOLOGIES, INC. SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL 09/22/1998
K973462 TISSUE TECHNOLOGIES, INC. SOFTFORM FACIAL IMPLANT 11/24/1997
K000849 TISSUE TECHNOLOGIES, INC. SOFTFORM FACIAL IMPLANT 05/19/2000
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
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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
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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
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K915526 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH 05/29/1992
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
K905655 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC NONABSORBABLE POLYPROPYLENE SURGICAL MESH 12/31/1990
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K063435 W. L. GORE & ASSOCIATES, INC. GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL 11/28/2006
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K000185 W.L. GORE & ASSOCIATES,INC GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM) 02/14/2000
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K931150 W.L. GORE & ASSOCIATES,INC GORE-TEX MICRO MESH 10/29/1993
K951675 W.L. GORE & ASSOCIATES,INC GORE-TEX MYCROMESH BIOMATERIAL 10/07/1995
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K952898 W.L. GORE & ASSOCIATES,INC GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER 11/14/1995
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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
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K930822 W.L. GORE & ASSOCIATES,INC GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH 01/28/1994
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K945899 W.L. GORE & ASSOCIATES,INC GORE-TEX(R) CURVED SURGICALMEMBRANE 02/13/1995
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K926565 W.L. GORE & ASSOCIATES,INC GORE-TEX(TM) DUAL MESH 09/09/1993
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
K833764 W.L. GORE & ASSOCIATES,INC STERILIZATION OF GORE-TEX SOFT TISSU 01/10/1984


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