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336 FDA 510(k) clearances · Product code

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RecordFirmDate
CALDERA MESH (K060004)Caldera Medical, Inc.2006-02-22
SPORTMESH (K052830)Artimplant AB2006-01-19
OPTILENE MESH LP (K053158)Aesculap, Inc.2006-01-18
TYRX SURGICAL MESH, MODEL SMPC-0501 (K052864)Tyrx Pharma, Inc.2005-12-22
SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH (K053066)Genzyme Corporation2005-12-19
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (K053200)W. L. Gore & Associates, Inc.2005-12-07
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL (K053202)W.L. Gore & Associates2005-12-07
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED (K052155)C.R. Bard, Inc.2005-10-20
VICRYL * MESH BAG (K051701)ETHICON, Inc.2005-09-29
INCLOSE SURGICAL MESH SYSTEM (K050969)Anulex Technologies, Inc.2005-08-18
MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH (K052100)Proxy Biomedical , Ltd.2005-08-11
ORTHOMEND (K051766)Tei Biosciences, Inc.2005-08-11
SURGI-WRAP MAST BIORESORBABLE SHEET (K050332)Mast Biosurgery USA, Inc.2005-05-27
MOTIFMESH SOFT TISSUE PATCH (K050678)Proxy Biomedical , Ltd.2005-05-20
TISSUE FIXATION SYSTEM (K050418)Tfs Manufacturing Pty, Ltd.2005-05-16
REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH (K043191)Angiologica B. M. Srl2005-05-16
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES (K050187)Sofradim Production2005-02-18
GORE POLYPROPYLENE HERNIA MESH (K043081)W. L. Gore & Associates, Inc.2004-12-22
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL (K043056)W. L. Gore & Associates, Inc.2004-12-22
PERMACOL SURGICAL IMPLANT (K043366)Tissue Science Laboratories, Plc2004-12-17
VIVOSORB SHEET, MODEL FS01 (K042811)Polyganics B.V.,2004-11-08
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004 (K042026)C.R. Bard, Inc.2004-09-10
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH (K040998)Sofradim Production2004-04-29
ULTRAPRO MESH (K033337)ETHICON, Inc.2004-04-01
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007 (K033814)C.R. Bard, Inc.2004-03-01
UGYTEX MESH (K033376)Sofradim Production2004-01-15
SHELHIGH NO-REACT BIOCUFF (K032893)Shelhigh, Inc.2003-12-19
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL (K032865)W. L. Gore & Associates, Inc.2003-11-28
IMMIX PLASTIFILM (K032673)Osteobiologics, Inc.2003-10-02
TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 (K031225)Gfe Medizintechnik GmbH2003-09-29
MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET (K031955)Macropore Biosurgery, Inc.2003-09-22
PROCEED TRILAMINATE SURGICAL MESH (K031925)ETHICON, Inc.2003-09-17
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL (K032168)W. L. Gore & Associates, Inc.2003-08-15
ORTHOMEND (K031188)Tei Biosciences, Inc.2003-06-27
ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH (K030631)Prosurg, Inc.2003-05-19
IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP (K024199)Osteobiologics, Inc.2003-03-14
V.A.C. ABDOMINAL DRESSING (K022011)Kinetic Concepts, Inc.2003-02-26
SMALL BARD VENTRALEX PATCH (K024008)C.R. Bard, Inc.2003-02-20
REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH (K023328)Center For Biomaterials and Advanced Technologies2002-12-12
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX (K021835)Brennen Medical, Inc.2002-10-17
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL (K022782)W. L. Gore & Associates, Inc.2002-09-10
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 (K022350)C.R. Bard, Inc.2002-08-23
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 (K021736)C.R. Bard, Inc.2002-07-16
AFB (ABSORBABLE FOAM BUTTRESS) (K014183)J&J Corporate Biomaterials Center2002-06-12
MACROPORE SURGIWRAP (TS) (K012025)Macropore Biosurgery, Inc.2001-12-03
BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH (K010533)Injectx, Inc.2001-05-24
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH (K010722)ETHICON, Inc.2001-04-27
IVS TUNNELLER (K010035)United States Surgical, A Division of Tyco Healthc2001-04-04
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES (K010228)W. L. Gore & Associates, Inc.2001-02-21
PARIETEX COMPOSITE (PCO) MESH (K002699)Medical Device Consultants, Inc.2001-02-15
MODIFICATION TO FLUOROTEX II SURGICAL MESH (K003917)Bridger Biomed, Inc.2001-01-26
MODIFICATION TO FLUROTEX SURGICAL MESH (K003906)Bridger Biomed, Inc.2001-01-26
SOFRADIM PARIETEX SURGICAL MESHES (K003990)Sofradim Production2001-01-24
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 (K003323)Davol, Inc.2001-01-22
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH (K002721)American Medical Systems, Inc.2000-11-29
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH (K002672)ETHICON, Inc.2000-11-22
BIOMESH P1 AND BIOMESH PLUG AND PATCH (K002479)Cousin Biotech S.A.R.L2000-10-19
COMPOSIX E/X MESH (K002684)C.R. Bard, Inc.2000-10-11
FLUOROTEX II SURGICAL MESH (K002351)Bridger Biomed, Inc.2000-08-26
SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES (K002071)Tissue Technologies, Inc.2000-07-24
ATRIUM LITE MESH (K002093)Atrium Medical Corp.2000-07-24
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH (K001122)ETHICON, Inc.2000-05-23
SOFTFORM FACIAL IMPLANT (K000849)Tissue Technologies, Inc.2000-05-19
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX (K994328)Genzyme Corp.2000-03-02
PERMACOL (K992556)Tissue Science Laboratories, Plc2000-02-17
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM) (K000185)W. L. Gore & Associates, Inc.2000-02-14
ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT (K992991)Atrium Medical Corp.2000-01-27
STAR TEMPORARY WOUND COVER (K983753)Osteogenics, Inc.1999-11-18
GORE-TEX DUALMESH BIOMATERIAL (K992189)W. L. Gore & Associates, Inc.1999-07-29
PARIETENE POLYPROPYLENE MESH (K991400)Sofradim Production1999-07-12
BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 (K991637)Davol Inc., Sub. C. R. Bard, Inc.1999-06-22
3D ANATOMICAL MESH (K990930)Santerra Medical Technology, Inc.1999-06-17
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH (K984220)ETHICON, Inc.1999-02-23
PARIETEX (K982532)Cogent1999-01-20
FLUOROTEX SURGICAL MESH (K984197)Bridger Biomed, Inc.1999-01-07
MESH, SURGICAL, POLYMERIC (K982575)United States Surgical, A Division of Tyco Healthc1998-11-06
SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL (K982475)Tissue Technologies, Inc.1998-09-22
SHELHIGH NO-REACT PNEUMOPLEDGETS (K981756)Shelhigh, Inc.1998-08-05
SIS HERNIA REPAIR DEVICE (K974540)Sentron Medical, Inc.1998-05-20
HERNIAMESH SURGICAL MESHES (K973955)Herniamesh1998-05-11
MENTOR SUSPEND SLING (K980483)Mentor Corp.1998-04-30
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES (K981051)W. L. Gore & Associates, Inc.1998-04-15
SOFTFORM FACIAL IMPLANT (K973462)Tissue Technologies, Inc.1997-11-24
VENTRAL WALL DEFECT REDUCTION SILO (K973082)Specialty Surgical Products, Inc.1997-11-04
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH (K972412)ETHICON, Inc.1997-09-10
BARD COMPOSITE PROSTHESIS (K971745)Davol Inc., Sub. C. R. Bard, Inc.1997-08-06
GRAFT PATCH (K970561)Organogenesis, Inc.1997-08-01
SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA (K971472)Technical Products, Inc.1997-07-01
RAPISEAL PATCH (K964857)Fusion Medical Technologies, Inc.1997-02-18
GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE (K965038)W. L. Gore & Associates, Inc.1997-02-06
S.A.M. FACIAL IMPLANT W/INTRODUCER (K964761)W. L. Gore & Associates, Inc.1997-01-27
SURGICAL FABRICS (K963226)Boston Scientific Corp1996-11-15
GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES (K963619)W. L. Gore & Associates, Inc.1996-10-25
KUGEL HERNIA PATCH (K963141)Douglas Bueschel1996-10-11
POLYPROPYLENE MESH (VARIOUS SIZES) (K962971)Davis & Geck, Inc.1996-09-16
SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.) (K962496)Tissue Technologies, Inc.1996-09-03
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES (K962401)W. L. Gore & Associates, Inc.1996-09-03
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH (K962530)ETHICON, Inc.1996-08-09
SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH (K961440)Fusion Medical Technologies, Inc.1996-05-31
SOFT TISSUE AUGMENTATION TUBE (K960481)Tissue Technologies, Inc.1996-04-01
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