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 |
|---|---|---|---|
| Feb 15, 2001 | K002699 | PARIETEX COMPOSITE (PCO) MESH Medical Device Consultants, Inc. | FTL |
| Jan 26, 2001 | K003917 | MODIFICATION TO FLUOROTEX II SURGICAL MESH Bridger Biomed, Inc. | FTL |
| Jan 26, 2001 | K003906 | MODIFICATION TO FLUROTEX SURGICAL MESH Bridger Biomed, Inc. | FTL |
| Jan 24, 2001 | K003990 | SOFRADIM PARIETEX SURGICAL MESHES Sofradim Production | FTL |
| Jan 22, 2001 | K003323 | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 Davol, Inc. | FTL |
| Nov 29, 2000 | K002721 | AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH American Medical Systems, Inc. | FTL |
| Nov 22, 2000 | K002672 | VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, Inc. | FTL |
| Oct 19, 2000 | K002479 | BIOMESH P1 AND BIOMESH PLUG AND PATCH Cousin Biotech S.A.R.L | FTL |
| Oct 11, 2000 | K002684 | COMPOSIX E/X MESH C.R. Bard, Inc. | FTL |
| Aug 26, 2000 | K002351 | FLUOROTEX II SURGICAL MESH Bridger Biomed, Inc. | FTL |
| Jul 24, 2000 | K002093 | ATRIUM LITE MESH Atrium Medical Corp. | FTL |
| Jul 24, 2000 | K002071 | SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES Tissue Technologies, Inc. | FTL |
| May 23, 2000 | K001122 | PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH ETHICON, Inc. | FTL |
| May 19, 2000 | K000849 | SOFTFORM FACIAL IMPLANT Tissue Technologies, Inc. | FTL |
| Mar 2, 2000 | K994328 | SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX Genzyme Corp. | FTL |
| Feb 17, 2000 | K992556 | PERMACOL Tissue Science Laboratories, Plc | FTL |
| Feb 14, 2000 | K000185 | GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM) W. L. Gore & Associates, Inc. | FTL |
| Jan 27, 2000 | K992991 | ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT Atrium Medical Corp. | FTL |
| Nov 18, 1999 | K983753 | STAR TEMPORARY WOUND COVER Osteogenics, Inc. | FTL |
| Jul 29, 1999 | K992189 | GORE-TEX DUALMESH BIOMATERIAL W. L. Gore & Associates, Inc. | FTL |
| Jul 12, 1999 | K991400 | PARIETENE POLYPROPYLENE MESH Sofradim Production | FTL |
| Jun 22, 1999 | K991637 | BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 Davol Inc., Sub. C. R. Bard, Inc. | FTL |
| Jun 17, 1999 | K990930 | 3D ANATOMICAL MESH Santerra Medical Technology, Inc. | FTL |
| Feb 23, 1999 | K984220 | MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, Inc. | FTL |
| Jan 20, 1999 | K982532 | PARIETEX Cogent | FTL |
| Jan 7, 1999 | K984197 | FLUOROTEX SURGICAL MESH Bridger Biomed, Inc. | FTL |
| Nov 6, 1998 | K982575 | MESH, SURGICAL, POLYMERIC United States Surgical, A Division of Tyco Healthc | FTL |
| Sep 22, 1998 | K982475 | SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL Tissue Technologies, Inc. | FTL |
| Aug 5, 1998 | K981756 | SHELHIGH NO-REACT PNEUMOPLEDGETS Shelhigh, Inc. | FTL |
| May 20, 1998 | K974540 | SIS HERNIA REPAIR DEVICE Sentron Medical, Inc. | FTL |
| May 11, 1998 | K973955 | HERNIAMESH SURGICAL MESHES Herniamesh | FTL |
| Apr 30, 1998 | K980483 | MENTOR SUSPEND SLING Mentor Corp. | FTL |
| Apr 15, 1998 | K981051 | SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES W. L. Gore & Associates, Inc. | FTL |
| Nov 24, 1997 | K973462 | SOFTFORM FACIAL IMPLANT Tissue Technologies, Inc. | FTL |
| Nov 4, 1997 | K973082 | VENTRAL WALL DEFECT REDUCTION SILO Specialty Surgical Products, Inc. | FTL |
| Sep 10, 1997 | K972412 | PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, Inc. | FTL |
| Aug 6, 1997 | K971745 | BARD COMPOSITE PROSTHESIS Davol Inc., Sub. C. R. Bard, Inc. | FTL |
| Aug 1, 1997 | K970561 | GRAFT PATCH Organogenesis, Inc. | FTL |
| Jul 1, 1997 | K971472 | SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA Technical Products, Inc. | FTL |
| Feb 18, 1997 | K964857 | RAPISEAL PATCH Fusion Medical Technologies, Inc. | FTL |
| Feb 6, 1997 | K965038 | GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE W. L. Gore & Associates, Inc. | FTL |
| Jan 27, 1997 | K964761 | S.A.M. FACIAL IMPLANT W/INTRODUCER W. L. Gore & Associates, Inc. | FTL |
| Nov 15, 1996 | K963226 | SURGICAL FABRICS Boston Scientific Corp | FTL |
| Oct 25, 1996 | K963619 | GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES W. L. Gore & Associates, Inc. | FTL |
| Oct 11, 1996 | K963141 | KUGEL HERNIA PATCH Douglas Bueschel | FTL |
| Sep 16, 1996 | K962971 | POLYPROPYLENE MESH (VARIOUS SIZES) Davis & Geck, Inc. | FTL |
| Sep 3, 1996 | K962496 | SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.) Tissue Technologies, Inc. | FTL |
| Sep 3, 1996 | K962401 | GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES W. L. Gore & Associates, Inc. | FTL |
| Aug 9, 1996 | K962530 | PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, Inc. | FTL |
| May 31, 1996 | K961440 | SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH Fusion Medical Technologies, Inc. | FTL |
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