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 22, 2006 | K060004 | CALDERA MESH Caldera Medical, Inc. | FTL |
| Feb 22, 2006 | K053424 | POPMESH Caldera Medical, Inc. | FTL |
| Jan 19, 2006 | K052830 | SPORTMESH Artimplant AB | FTL |
| Jan 18, 2006 | K053158 | OPTILENE MESH LP Aesculap, Inc. | FTL |
| Dec 22, 2005 | K052864 | TYRX SURGICAL MESH, MODEL SMPC-0501 Tyrx Pharma, Inc. | FTL |
| Dec 19, 2005 | K053066 | SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH Genzyme Corporation | FTL |
| Dec 7, 2005 | K053202 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W.L. Gore & Associates | FTL |
| Dec 7, 2005 | K053200 | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc. | FTL |
| Oct 20, 2005 | K052155 | BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED C.R. Bard, Inc. | FTL |
| Sep 29, 2005 | K051701 | VICRYL * MESH BAG ETHICON, Inc. | FTL |
| Aug 18, 2005 | K050969 | INCLOSE SURGICAL MESH SYSTEM Anulex Technologies, Inc. | FTL |
| Aug 11, 2005 | K052100 | MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH Proxy Biomedical , Ltd. | FTL |
| Aug 11, 2005 | K051766 | ORTHOMEND Tei Biosciences, Inc. | FTL |
| May 27, 2005 | K050332 | SURGI-WRAP MAST BIORESORBABLE SHEET Mast Biosurgery USA, Inc. | FTL |
| May 20, 2005 | K050678 | MOTIFMESH SOFT TISSUE PATCH Proxy Biomedical , Ltd. | FTL |
| May 16, 2005 | K050418 | TISSUE FIXATION SYSTEM Tfs Manufacturing Pty, Ltd., AU | FTL |
| May 16, 2005 | K043191 | REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH Angiologica B. M. Srl, IT | FTL |
| Feb 18, 2005 | K050187 | PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES Sofradim Production | FTL |
| Dec 22, 2004 | K043081 | GORE POLYPROPYLENE HERNIA MESH W. L. Gore & Associates, Inc. | FTL |
| Dec 22, 2004 | K043056 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc. | FTL |
| Dec 17, 2004 | K043366 | PERMACOL SURGICAL IMPLANT Tissue Science Laboratories, Plc | FTL |
| Nov 8, 2004 | K042811 | VIVOSORB SHEET, MODEL FS01 Polyganics B.V.,, NL | FTL |
| Sep 10, 2004 | K042026 | BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004 C.R. Bard, Inc. | FTL |
| Apr 29, 2004 | K040998 | MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH Sofradim Production | FTL |
| Apr 1, 2004 | K033337 | ULTRAPRO MESH ETHICON, Inc. | FTL |
| Mar 1, 2004 | K033814 | BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007 C.R. Bard, Inc. | FTL |
| Jan 15, 2004 | K033376 | UGYTEX MESH Sofradim Production | FTL |
| Dec 19, 2003 | K032893 | SHELHIGH NO-REACT BIOCUFF Shelhigh, Inc. | FTL |
| Nov 28, 2003 | K032865 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc. | FTL |
| Oct 2, 2003 | K032673 | IMMIX PLASTIFILM Osteobiologics, Inc. | FTL |
| Sep 29, 2003 | K031225 | TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 Gfe Medizintechnik GmbH | FTL |
| Sep 22, 2003 | K031955 | MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET Macropore Biosurgery, Inc. | FTL |
| Sep 17, 2003 | K031925 | PROCEED TRILAMINATE SURGICAL MESH ETHICON, Inc. | FTL |
| Aug 15, 2003 | K032168 | GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL W. L. Gore & Associates, Inc. | FTL |
| Jun 27, 2003 | K031188 | ORTHOMEND Tei Biosciences, Inc. | FTL |
| May 19, 2003 | K030631 | ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH Prosurg, Inc. | FTL |
| Mar 14, 2003 | K024199 | IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP Osteobiologics, Inc. | FTL |
| Feb 26, 2003 | K022011 | V.A.C. ABDOMINAL DRESSING Kinetic Concepts, Inc. | FTL |
| Feb 20, 2003 | K024008 | SMALL BARD VENTRALEX PATCH C.R. Bard, Inc. | FTL |
| Dec 12, 2002 | K023328 | REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH Center For Biomaterials and Advanced Technologies | FTL |
| Oct 17, 2002 | K021835 | BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX Brennen Medical, Inc. | FTL |
| Sep 10, 2002 | K022782 | DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL W. L. Gore & Associates, Inc. | FTL |
| Aug 23, 2002 | K022350 | BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 C.R. Bard, Inc. | FTL |
| Jul 16, 2002 | K021736 | BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 C.R. Bard, Inc. | FTL |
| Jun 12, 2002 | K014183 | AFB (ABSORBABLE FOAM BUTTRESS) J&J Corporate Biomaterials Center | FTL |
| Dec 3, 2001 | K012025 | MACROPORE SURGIWRAP (TS) Macropore Biosurgery, Inc. | FTL |
| May 24, 2001 | K010533 | BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH Injectx, Inc. | FTL |
| Apr 27, 2001 | K010722 | PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, Inc. | FTL |
| Apr 4, 2001 | K010035 | IVS TUNNELLER United States Surgical, A Division of Tyco Healthc | FTL |
| Feb 21, 2001 | K010228 | GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES W. L. Gore & Associates, Inc. | FTL |
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