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FTL

336 FDA 510(k) clearances · Product code

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RecordFirmDate
PROLEX MESH (K960219)Advanced Surgical Innovations, Inc.1996-03-15
GLYCAR STAPLE STRIPS (K954665)Glycar, Inc.1996-02-14
GORE-TEX DUALMESH BIOMATERIAL WITH HOLES (K955494)W. L. Gore & Associates, Inc.1996-01-24
GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER (K952898)W. L. Gore & Associates, Inc.1995-11-14
GORE-TEX SOFT TISSUE PATCH (K951700)W. L. Gore & Associates, Inc.1995-10-07
GORE-TEX DUALMESH BIOMATERIAL (K951676)W. L. Gore & Associates, Inc.1995-10-07
GORE-TEX MYCROMESH BIOMATERIAL (K951675)W. L. Gore & Associates, Inc.1995-10-07
BARD VISILEX MESH 3 X 6 (K953577)Davol Inc., Sub. C. R. Bard, Inc.1995-09-26
GORE-TEX DUALMESH PLUS BIOMATERIAL (K946106)W. L. Gore & Associates, Inc.1995-04-24
GORE-TEX MYCROMESH PLUS BIOMATERIAL (K946107)W. L. Gore & Associates, Inc.1995-04-24
HERNIA MESH INTRODUCTION SYSTEM (K945060)Gerard Medical, Inc.1995-03-02
GORE-TEX(R) CURVED SURGICALMEMBRANE (K945899)W. L. Gore & Associates, Inc.1995-02-13
GLYCAR TISSUE REPAIR PATCH (K942911)Glycar, Inc.1994-12-14
TRELEX NATURAL(R) MESH (K945377)Meadox Medicals, Div. Boston Scientific Corp.1994-12-08
ACM PTFE SURGICAL MESH (K944413)American Custom Medical, Inc.1994-11-09
GORE-TEX SOFT TISSUE PATCH PLUS (K922452)W. L. Gore & Associates, Inc.1994-09-29
FLARED PATCH (K941299)Flared Patch, Inc.1994-08-23
PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT (K942583)Bio-Vascular, Inc.1994-07-08
BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS (K933827)Bioplexus Corp.1994-06-30
GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH (K930822)W. L. Gore & Associates, Inc.1994-01-28
GIANTURCO-HELFRICH HERNIS MESH (K931936)Cook, Inc.1994-01-10
ATRIUM POLYPROPYLENE MESH (K930669)Atrium Medical Corp.1993-12-16
GORE-TEK(R) SOFT TISSUE PATCH (K926478)W. L. Gore & Associates, Inc.1993-11-29
GORE-TEX MICRO MESH (K931150)W. L. Gore & Associates, Inc.1993-10-29
GORE-TEX(TM) DUAL MESH (K926565)W. L. Gore & Associates, Inc.1993-09-09
AUTO SUTURE SURGICAL MESH DEPLOYER (K925148)United States Surgical, A Division of Tyco Healthc1993-02-12
TRELEX MESH (K924749)Meadox Medicals, Div. Boston Scientific Corp.1992-11-23
BARD MARLEX MESH DART (K922916)C.R. Bard, Inc.1992-08-24
COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH (K915526)United States Surgical, A Division of Tyco Healthc1992-05-29
GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE (K914449)W. L. Gore & Associates, Inc.1991-12-04
NONABSORBABLE POLYPROPYLENE SURGICAL MESH (K905655)United States Surgical, A Division of Tyco Healthc1990-12-31
VENTRAL WALL DEFECT REDUCT SILO (K840172)American Heyer Schulte1984-06-27
STERILIZATION OF GORE-TEX SOFT TISSU (K833764)W. L. Gore & Associates, Inc.1984-01-10
GORE-TEX TISSUE REINFORCEMENT PATCH (K820193)W. L. Gore & Associates, Inc.1982-03-26
VICRYL (K810428)ETHICON, Inc.1981-03-13
USHER'S MARLEX TUBULAR MESH (K792281)Davol, Inc.1979-11-27
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