Panels › General, Plastic Surgery › Product code FTL · Class 2
Mesh, Surgical, Polymeric
Regulation 878.3300
2510(k)s in 12 months (337 all time)
0recalls in 12 months (73 all time)
58recalls that name a 510(k)
Top companies in FTL
| Company | 510(k)s | Recalls |
|---|---|---|
| W. L. Gore & Associates, Inc. | 37 | 1 |
| Sofradim Production | 36 | 1 |
| ETHICON, Inc. | 25 | 3 |
| C. R. Bard | 26 | 0 |
| Davol Inc., Sub. C. R. Bard, Inc. | 8 | 17 |
| Atrium Medical Corp. | 14 | 5 |
| Davol, Inc. | 4 | 4 |
| Tyrx, Inc. | 5 | 3 |
| American Medical Systems, Inc. | 3 | 4 |
| Covidien | 1 | 5 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 1, 1996 | K960481 | SOFT TISSUE AUGMENTATION TUBE Tissue Technologies, Inc. | FTL |
| Mar 15, 1996 | K960219 | PROLEX MESH Advanced Surgical Innovations, Inc., CA | FTL |
| Feb 14, 1996 | K954665 | GLYCAR STAPLE STRIPS Glycar, Inc. | FTL |
| Jan 24, 1996 | K955494 | GORE-TEX DUALMESH BIOMATERIAL WITH HOLES W. L. Gore & Associates, Inc. | FTL |
| Nov 14, 1995 | K952898 | GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER W. L. Gore & Associates, Inc. | FTL |
| Oct 7, 1995 | K951700 | GORE-TEX SOFT TISSUE PATCH W. L. Gore & Associates, Inc. | FTL |
| Oct 7, 1995 | K951676 | GORE-TEX DUALMESH BIOMATERIAL W. L. Gore & Associates, Inc. | FTL |
| Oct 7, 1995 | K951675 | GORE-TEX MYCROMESH BIOMATERIAL W. L. Gore & Associates, Inc. | FTL |
| Sep 26, 1995 | K953577 | BARD VISILEX MESH 3 X 6 Davol Inc., Sub. C. R. Bard, Inc. | FTL |
| Apr 24, 1995 | K946107 | GORE-TEX MYCROMESH PLUS BIOMATERIAL W. L. Gore & Associates, Inc. | FTL |
| Apr 24, 1995 | K946106 | GORE-TEX DUALMESH PLUS BIOMATERIAL W. L. Gore & Associates, Inc. | FTL |
| Mar 2, 1995 | K945060 | HERNIA MESH INTRODUCTION SYSTEM Gerard Medical, Inc. | FTL |
| Feb 13, 1995 | K945899 | GORE-TEX(R) CURVED SURGICALMEMBRANE W. L. Gore & Associates, Inc. | FTL |
| Dec 14, 1994 | K942911 | GLYCAR TISSUE REPAIR PATCH Glycar, Inc. | FTL |
| Dec 8, 1994 | K945377 | TRELEX NATURAL(R) MESH Meadox Medicals, Div. Boston Scientific Corp. | FTL |
| Nov 9, 1994 | K944413 | ACM PTFE SURGICAL MESH American Custom Medical, Inc. | FTL |
| Sep 29, 1994 | K922452 | GORE-TEX SOFT TISSUE PATCH PLUS W. L. Gore & Associates, Inc. | FTL |
| Aug 23, 1994 | K941299 | FLARED PATCH Flared Patch, Inc. | FTL |
| Jul 8, 1994 | K942583 | PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT Bio-Vascular, Inc. | FTL |
| Jun 30, 1994 | K933827 | BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS Bioplexus Corp. | FTL |
| Jan 28, 1994 | K930822 | GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH W. L. Gore & Associates, Inc. | FTL |
| Jan 10, 1994 | K931936 | GIANTURCO-HELFRICH HERNIS MESH Cook, Inc. | FTL |
| Dec 16, 1993 | K930669 | ATRIUM POLYPROPYLENE MESH Atrium Medical Corp. | FTL |
| Nov 29, 1993 | K926478 | GORE-TEK(R) SOFT TISSUE PATCH W. L. Gore & Associates, Inc. | FTL |
| Oct 29, 1993 | K931150 | GORE-TEX MICRO MESH W. L. Gore & Associates, Inc. | FTL |
| Sep 9, 1993 | K926565 | GORE-TEX(TM) DUAL MESH W. L. Gore & Associates, Inc. | FTL |
| Feb 12, 1993 | K925148 | AUTO SUTURE SURGICAL MESH DEPLOYER United States Surgical, A Division of Tyco Healthc | FTL |
| Nov 23, 1992 | K924749 | TRELEX MESH Meadox Medicals, Div. Boston Scientific Corp. | FTL |
| Aug 24, 1992 | K922916 | BARD MARLEX MESH DART C.R. Bard, Inc. | FTL |
| May 29, 1992 | K915526 | COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH United States Surgical, A Division of Tyco Healthc | FTL |
| Dec 4, 1991 | K914449 | GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE W. L. Gore & Associates, Inc. | FTL |
| Dec 31, 1990 | K905655 | NONABSORBABLE POLYPROPYLENE SURGICAL MESH United States Surgical, A Division of Tyco Healthc | FTL |
| Jun 27, 1984 | K840172 | VENTRAL WALL DEFECT REDUCT SILO American Heyer Schulte | FTL |
| Jan 10, 1984 | K833764 | STERILIZATION OF GORE-TEX SOFT TISSU W. L. Gore & Associates, Inc. | FTL |
| Mar 26, 1982 | K820193 | GORE-TEX TISSUE REINFORCEMENT PATCH W. L. Gore & Associates, Inc. | FTL |
| Mar 13, 1981 | K810428 | VICRYL ETHICON, Inc. | FTL |
| Nov 27, 1979 | K792281 | USHER'S MARLEX TUBULAR MESH Davol, Inc. | FTL |
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