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 |
|---|---|---|---|
| Aug 13, 2008 | K081126 | PARIETEX COMPOSITE MONO PM MESH Sofradim Production | FTL |
| Jul 24, 2008 | K072370 | SURGICRAFT SURGICAL MESH SYSTEM Surgicraft , Ltd. | FTL |
| Jun 26, 2008 | K072962 | CABS'AIR Cousin Biotech Sas, FR | FTL |
| Jun 19, 2008 | K081327 | RELIMESH Herniamesh S.R.L. | FTL |
| May 30, 2008 | K081069 | GORE INFINIT MESH W. L. Gore & Associates, Inc. | FTL |
| May 28, 2008 | K081050 | PARIETEX PROGRIP MESH Sofradim Production | FTL |
| Apr 21, 2008 | K080836 | MODIFICATION TO ENDOFAST RELIANT SYSTEM Endogun Medical Systems, IL | FTL |
| Apr 16, 2008 | K080691 | C-QUR EDGE MESH V-PATCH Atrium Medical Corp. | FTL |
| Apr 16, 2008 | K080688 | C-QUR LITE MESH V-PATCH Atrium Medical Corp. | FTL |
| Apr 3, 2008 | K080353 | LTM-T SURGICAL MESH Lifecell Corp. | FTL |
| Mar 13, 2008 | K080393 | MODIFICATION TO REBOUND HRD Minnesota Medical Development, Inc. | FTL |
| Mar 13, 2008 | K073287 | PREVADH MESH Sofradim Production | FTL |
| Mar 5, 2008 | K073164 | IVS TUNNELLER DEVICES Covidien UK Manufacturing, Ltd. | FTL |
| Feb 25, 2008 | K070961 | BIOMERIX SURGICAL MESH, MODEL: RCR-01 Biomerix Corporation | FTL |
| Jan 16, 2008 | K072190 | ORTHO-WRAP BIORESORBABLE SHEET Mast Biosurgery | FTL |
| Jan 16, 2008 | K063091 | PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 Tyrx Pharma, Inc. | FTL |
| Dec 31, 2007 | K071695 | KENSEY NASH MACROPORE SHIELD Kensey Nash Corp. | FTL |
| Nov 29, 2007 | K072520 | TEPHAFLEX SURGICAL FILM Tepha, Inc. | FTL |
| Sep 18, 2007 | K071887 | SPORTMESH OR ARTELON TISSUE REINFORCEMENT Artimplant AB | FTL |
| Aug 31, 2007 | K071470 | IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX Implantech Associates, Inc. | FTL |
| Aug 22, 2007 | K070918 | 4DDOME Cousin Biotech | FTL |
| Aug 16, 2007 | K063671 | REBOUND HRD Minnesota Medical Development, Inc. | FTL |
| Aug 1, 2007 | K070625 | PELVIMESH / HERMESH 7 Marketing Solutions, Inc. | FTL |
| Jul 17, 2007 | K061934 | XTAC Osteogenics, Inc. | FTL |
| Jul 10, 2007 | K071629 | PARIETEX POLYESTER MESH WITH INTRODUCER Sofradim Production | FTL |
| Jul 10, 2007 | K063154 | FACIAL RECONSTRUCTIVE MESH (FRM) Evera Medical, Inc. | FTL |
| Jul 2, 2007 | K070846 | MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM Prosurg, Inc. | FTL |
| Jun 5, 2007 | K071249 | ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV ETHICON, Inc. | FTL |
| May 9, 2007 | K070993 | TOPAS SYSTEM American Medical Systems, Inc. | FTL |
| Apr 27, 2007 | K070018 | UNIVERSAL SURGICAL MESH, MODEL 100 Generic Medical Device, Inc. | FTL |
| Apr 17, 2007 | K070224 | ULTRAPRO PLUG ETHICON, Inc. | FTL |
| Apr 2, 2007 | K070644 | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS W. L. Gore & Associates, Inc. | FTL |
| Mar 8, 2007 | K070192 | ATRIUM PROLITE ULTRA S MESH Atrium Medical Corp. | FTL |
| Mar 7, 2007 | K063648 | SURGI-WRAP MAST TENDON SHEET Mast Biosurgery USA, Inc. | FTL |
| Feb 1, 2007 | K061445 | SURGIMESH WN Aspide Medical | FTL |
| Jan 17, 2007 | K063739 | SEPRAMESH, MODEL 5959-1214 Genzyme Corporation | FTL |
| Dec 11, 2006 | K061533 | PROCEED VENTRAL PATCH ETHICON, Inc. | FTL |
| Nov 28, 2006 | K063435 | GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL W. L. Gore & Associates, Inc. | FTL |
| Oct 23, 2006 | K061754 | BARD COMPOSITE L/P MESH Davol Inc., Sub. C. R. Bard, Inc. | FTL |
| Oct 13, 2006 | K062697 | SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT Cook Biotech, Inc. | FTL |
| Sep 21, 2006 | K061473 | SURGI-WRAP MAST BIORESORBABLE SHEET Mast Biosurgery USA, Inc. | FTL |
| Sep 11, 2006 | K060329 | ENDOFAST RELIANT SYSTEM Endogun Medical Systems, IL | FTL |
| Jul 26, 2006 | K060018 | TRULENE MESH Sutures India Pvt., Ltd., IN | FTL |
| Jul 19, 2006 | K061704 | OPTILENE MESH Aesculap, Inc. | FTL |
| Jul 17, 2006 | K053215 | SURGICAL MESH SYSTEM Nuvasive, Inc. | FTL |
| Jul 14, 2006 | K053656 | TYRX ANTIMICROBIAL MESH Tyrx Pharma, Inc. | FTL |
| Jun 2, 2006 | K061314 | BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH Davol Inc., Sub. C. R. Bard, Inc. | FTL |
| May 25, 2006 | K060713 | PROCEED SURGICAL MESH ETHICON, Inc. | FTL |
| Mar 31, 2006 | K050311 | ATRIUM MEDICAL CORPORATION C-QUR MESH Atrium Medical Corp. | FTL |
| Mar 28, 2006 | K060520 | VITAMESH MACROPOROUS PP SURGICAL MESH Proxy Biomedical , Ltd. | FTL |
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