FDA Product Code
FDA Product Code FTL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 337 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K111121 | VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH | Proxy Biomedical , Ltd. | 2011-05-13 | Special | PDF ↗ |
| K102788 | TORNIER BIOFIBER SCAFFOLD | Tornier, Inc. | 2011-05-10 | Traditional | PDF ↗ |
| K110816 | PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES) | Sofradim Production | 2011-04-19 | Special | PDF ↗ |
| K110815 | PARIETEX OPTIMIZED COMPOSTIE MESH | Sofradim Production | 2011-04-19 | Special | PDF ↗ |
| K110820 | VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM | C.R. Bard, Inc. | 2011-04-01 | Special | PDF ↗ |
| K101920 | VENTRIO ST HERNIA PATCH | C.R. Bard, Inc. | 2011-03-23 | Traditional | PDF ↗ |
| K101928 | VENTRALEX ST HERNIA PATCH | C.R. Bard, Inc. | 2011-03-23 | Traditional | PDF ↗ |
| K103682 | PARIETEX PROGRIP | Sofradim Production | 2011-03-04 | Special | PDF ↗ |
| K103445 | ALACER SURGICAL SCAFFOLD | Alacer Biomedical, Inc. | 2011-02-22 | Traditional | PDF ↗ |
| K110110 | ATRIUM CENTRILFX MESH | Atrium Medical Corporation | 2011-02-15 | Special | PDF ↗ |
| K103568 | RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH | Coloplast A/S | 2010-12-22 | Special | PDF ↗ |
| K102766 | COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM | C.R. Bard, Inc. | 2010-12-16 | Traditional | PDF ↗ |
| K101519 | PARIETEX PLUG AND PATCH | Sofradim Production | 2010-11-05 | Traditional | PDF ↗ |
| K100787 | RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT | Smith & Nephew, Inc. | 2010-09-17 | Traditional | PDF ↗ |
| K101462 | ASCEND BLUE AC MESH; ASCEND BLUE PC MESH | Caldera Medical, Inc. | 2010-08-16 | Special | PDF ↗ |
| K101851 | VENTRALIGHT ST MESH | Davol Inc., Sub. C. R. Bard, Inc. | 2010-07-15 | Special | PDF ↗ |
| K093196 | BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 | Cousin Biotech Sas | 2010-06-25 | Abbreviated | PDF ↗ |
| K092233 | SURGIMESH XD | Aspide Medical | 2010-06-25 | Traditional | PDF ↗ |
| K093123 | BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB | Biomerix Corporation | 2010-05-13 | Traditional | PDF ↗ |
| K101197 | PARIE TENE PROGRIP MESH | Sofradim Production | 2010-05-05 | Special | PDF ↗ |
| K093799 | TORNIER SURGICAL MESH | Tornier, Inc. | 2010-04-22 | Traditional | PDF ↗ |
| K100229 | VENTRIO HERNIA PATCH | C.R. Bard, Inc. | 2010-04-21 | Special | PDF ↗ |
| K093932 | ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH | Ethicon GmbH | 2010-04-09 | Traditional | PDF ↗ |
| K093524 | PIVIT A/B ST AND PIVIT A/B ST-R | Tyrx, Inc. | 2010-03-26 | Traditional | PDF ↗ |
| K092538 | REFINE SUPPORT SYSTEM, MODEL 100.0100 | Alure Medical, Inc. | 2010-03-05 | Traditional | PDF ↗ |
| K100076 | ATRIUM C-QUR OVT MESH | Atrium Medical Corp. | 2010-01-26 | Special | PDF ↗ |
| K092224 | TIGR SURGICAL MESH , MODEL WK-6 | Novus Scientific Pte, Ltd. | 2010-01-25 | Traditional | PDF ↗ |
| K090271 | HYDROCOAT MESH | Promethean Surgical Devices, Inc. | 2010-01-14 | Traditional | PDF ↗ |
| K092032 | BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 | Davol Inc., Sub. C. R. Bard, Inc. | 2009-12-08 | Traditional | PDF ↗ |
| K093166 | WITTMANN PATCH | Aperta, LLC | 2009-12-07 | Traditional | PDF ↗ |
| K091659 | BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732 | C.R. Bard, Inc. | 2009-08-03 | Traditional | PDF ↗ |
| K090909 | C-QUR V -PATCH MESH | Atrium Medical Corp. | 2009-06-04 | Special | PDF ↗ |
| K090934 | PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM | American Medical Systems, Inc. | 2009-06-02 | Special | PDF ↗ |
| K090489 | ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 | Kci USA, Inc. | 2009-05-14 | Special | PDF ↗ |
| K083102 | REFINE LIFT SYSTEM | Alure Medical, Inc. | 2009-05-11 | Traditional | PDF ↗ |
| K090858 | PARIETEX MONOFILAMENT POLYESTER MESH | Sofradim Production | 2009-05-06 | Traditional | PDF ↗ |
| K090288 | ORTHADAPT PR | Pegasus Biologics, Inc. | 2009-05-05 | Traditional | PDF ↗ |
| K083467 | REBOUND HRDV | Minnesota Medical Development, Inc. | 2009-04-23 | Special | PDF ↗ |
| K083307 | SYNTHASOME X-REPAIR | Synthasome, Inc. | 2009-03-27 | Traditional | PDF ↗ |
| K083266 | GORE BIO-A FISTULA PLUG | W. L. Gore & Associates, Inc. | 2009-03-27 | Traditional | PDF ↗ |
| K081377 | NUVASIVE SURGICAL MESH SYSTEM | Nuvasive, Inc. | 2009-01-15 | Special | PDF ↗ |
| K082748 | ATRIUM PROLITE S MESH | Atrium Medical Corp. | 2009-01-14 | Special | PDF ↗ |
| K082941 | BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 | Biomerix Corporation | 2009-01-07 | Traditional | PDF ↗ |
| K080442 | SERISCAFFOLD SURGICAL MESH | Serica Technologies, Inc. | 2008-11-13 | Traditional | PDF ↗ |
| K081010 | BARD 3DMAX MESH | Davol Inc., Sub. C. R. Bard, Inc. | 2008-10-07 | Traditional | PDF ↗ |
| K081777 | VENTRIO HERNIA PATCH | C.R. Bard, Inc. | 2008-09-29 | Traditional | PDF ↗ |
| K080216 | SUPRAMESH EXTRA | S. Jackson, Inc. | 2008-09-15 | Traditional | PDF ↗ |
| K082216 | TBD ETHICON MESH | ETHICON, Inc. | 2008-09-05 | Special | PDF ↗ |
| K072974 | SURGIMESH XB | Aspide Medical | 2008-08-18 | Traditional | PDF ↗ |
| K073579 | DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN | Feg Textiltechnik Forschungs-Und Entwicklungsgesel | 2008-08-18 | Traditional | PDF ↗ |
| K081126 | PARIETEX COMPOSITE MONO PM MESH | Sofradim Production | 2008-08-13 | Traditional | PDF ↗ |
| K072370 | SURGICRAFT SURGICAL MESH SYSTEM | Surgicraft , Ltd. | 2008-07-24 | Traditional | PDF ↗ |
| K072962 | CABS'AIR | Cousin Biotech Sas | 2008-06-26 | Traditional | PDF ↗ |
| K081327 | RELIMESH | Herniamesh S.R.L. | 2008-06-19 | Traditional | PDF ↗ |
| K081069 | GORE INFINIT MESH | W. L. Gore & Associates, Inc. | 2008-05-30 | Abbreviated | PDF ↗ |
| K081050 | PARIETEX PROGRIP MESH | Sofradim Production | 2008-05-28 | Traditional | PDF ↗ |
| K080836 | MODIFICATION TO ENDOFAST RELIANT SYSTEM | Endogun Medical Systems | 2008-04-21 | Special | PDF ↗ |
| K080688 | C-QUR LITE MESH V-PATCH | Atrium Medical Corp. | 2008-04-16 | Special | PDF ↗ |
| K080691 | C-QUR EDGE MESH V-PATCH | Atrium Medical Corp. | 2008-04-16 | Special | PDF ↗ |
| K080353 | LTM-T SURGICAL MESH | Lifecell Corp. | 2008-04-03 | Traditional | PDF ↗ |
| K073287 | PREVADH MESH | Sofradim Production | 2008-03-13 | Traditional | PDF ↗ |
| K080393 | MODIFICATION TO REBOUND HRD | Minnesota Medical Development, Inc. | 2008-03-13 | Special | PDF ↗ |
| K073164 | IVS TUNNELLER DEVICES | Covidien UK Manufacturing, Ltd. | 2008-03-05 | Traditional | PDF ↗ |
| K070961 | BIOMERIX SURGICAL MESH, MODEL: RCR-01 | Biomerix Corporation | 2008-02-25 | Traditional | PDF ↗ |
| K063091 | PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 | Tyrx Pharma, Inc. | 2008-01-16 | Traditional | PDF ↗ |
| K072190 | ORTHO-WRAP BIORESORBABLE SHEET | Mast Biosurgery | 2008-01-16 | Traditional | PDF ↗ |
| K071695 | KENSEY NASH MACROPORE SHIELD | Kensey Nash Corp. | 2007-12-31 | Traditional | PDF ↗ |
| K072520 | TEPHAFLEX SURGICAL FILM | Tepha, Inc. | 2007-11-29 | Traditional | PDF ↗ |
| K071887 | SPORTMESH OR ARTELON TISSUE REINFORCEMENT | Artimplant AB | 2007-09-18 | Traditional | PDF ↗ |
| K071470 | IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX | Implantech Associates, Inc. | 2007-08-31 | Traditional | PDF ↗ |
| K070918 | 4DDOME | Cousin Biotech | 2007-08-22 | Traditional | PDF ↗ |
| K063671 | REBOUND HRD | Minnesota Medical Development, Inc. | 2007-08-16 | Traditional | PDF ↗ |
| K070625 | PELVIMESH / HERMESH 7 | Marketing Solutions, Inc. | 2007-08-01 | Traditional | PDF ↗ |
| K061934 | XTAC | Osteogenics, Inc. | 2007-07-17 | Traditional | PDF ↗ |
| K071629 | PARIETEX POLYESTER MESH WITH INTRODUCER | Sofradim Production | 2007-07-10 | Special | PDF ↗ |
| K063154 | FACIAL RECONSTRUCTIVE MESH (FRM) | Evera Medical, Inc. | 2007-07-10 | Traditional | PDF ↗ |
| K070846 | MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM | Prosurg, Inc. | 2007-07-02 | Traditional | PDF ↗ |
| K071249 | ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV | ETHICON, Inc. | 2007-06-05 | Special | PDF ↗ |
| K070993 | TOPAS SYSTEM | American Medical Systems, Inc. | 2007-05-09 | Special | PDF ↗ |
| K070018 | UNIVERSAL SURGICAL MESH, MODEL 100 | Generic Medical Device, Inc. | 2007-04-27 | Traditional | PDF ↗ |
| K070224 | ULTRAPRO PLUG | ETHICON, Inc. | 2007-04-17 | Traditional | PDF ↗ |
| K070644 | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS | W. L. Gore & Associates, Inc. | 2007-04-02 | Special | PDF ↗ |
| K070192 | ATRIUM PROLITE ULTRA S MESH | Atrium Medical Corp. | 2007-03-08 | Special | PDF ↗ |
| K063648 | SURGI-WRAP MAST TENDON SHEET | Mast Biosurgery USA, Inc. | 2007-03-07 | Traditional | PDF ↗ |
| K061445 | SURGIMESH WN | Aspide Medical | 2007-02-01 | Traditional | PDF ↗ |
| K063739 | SEPRAMESH, MODEL 5959-1214 | Genzyme Corporation | 2007-01-17 | Traditional | PDF ↗ |
| K061533 | PROCEED VENTRAL PATCH | ETHICON, Inc. | 2006-12-11 | Traditional | PDF ↗ |
| K063435 | GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL | W. L. Gore & Associates, Inc. | 2006-11-28 | Special | PDF ↗ |
| K061754 | BARD COMPOSITE L/P MESH | Davol Inc., Sub. C. R. Bard, Inc. | 2006-10-23 | Traditional | PDF ↗ |
| K062697 | SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT | Cook Biotech, Inc. | 2006-10-13 | Special | PDF ↗ |
| K061473 | SURGI-WRAP MAST BIORESORBABLE SHEET | Mast Biosurgery USA, Inc. | 2006-09-21 | Traditional | PDF ↗ |
| K060329 | ENDOFAST RELIANT SYSTEM | Endogun Medical Systems | 2006-09-11 | Traditional | PDF ↗ |
| K060018 | TRULENE MESH | Sutures India Pvt., Ltd. | 2006-07-26 | Traditional | PDF ↗ |
| K061704 | OPTILENE MESH | Aesculap, Inc. | 2006-07-19 | Special | PDF ↗ |
| K053215 | SURGICAL MESH SYSTEM | Nuvasive, Inc. | 2006-07-17 | Traditional | PDF ↗ |
| K053656 | TYRX ANTIMICROBIAL MESH | Tyrx Pharma, Inc. | 2006-07-14 | Traditional | PDF ↗ |
| K061314 | BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH | Davol Inc., Sub. C. R. Bard, Inc. | 2006-06-02 | Traditional | PDF ↗ |
| K060713 | PROCEED SURGICAL MESH | ETHICON, Inc. | 2006-05-25 | Traditional | PDF ↗ |
| K050311 | ATRIUM MEDICAL CORPORATION C-QUR MESH | Atrium Medical Corp. | 2006-03-31 | Traditional | PDF ↗ |
| K060520 | VITAMESH MACROPOROUS PP SURGICAL MESH | Proxy Biomedical , Ltd. | 2006-03-28 | Abbreviated | PDF ↗ |
Product code FTL · Class II · General, Plastic Surgery. Data: openFDA.