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 |
|---|---|---|---|
| Jun 16, 2016 | K153632 | Endoform Reconstructive Template Aroa Biosurgery Limited (Formerly Mesynthes Limited), NZ | FTL |
| May 13, 2016 | K153236 | Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, L C.R. Bard, Inc. | FTL |
| Dec 11, 2015 | K152609 | GORE SYNECOR Biomaterial W. L. Gore & Associates, Inc. | FTL |
| Nov 17, 2015 | K152678 | TYRX Neuro Antibacterial Envelope Tyrx, Inc. | FTL |
| Oct 22, 2015 | K151386 | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic Atrium Medical Corporation | FTL |
| Sep 18, 2015 | K143743 | ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH C.R. Bard, Inc. | FTL |
| Aug 27, 2015 | K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug Atrium Medical Corporation | FTL |
| Jul 24, 2015 | K150906 | ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh Ehicon, Inc. | FTL |
| May 26, 2015 | K150091 | Versatex Monofilament Mesh Sofradim Production, FR | FTL |
| May 7, 2015 | K142192 | Insightra Freedom Ventral Hernia Repair System Insightra Medical | FTL |
| Mar 27, 2015 | K150291 | TYRX Neuro Absorbable Antibacterial Envelope Medtronic Tyrx, Inc. | FTL |
| Mar 25, 2015 | K142706 | Modified ONFLEX Mesh C.R. Bard, Inc. | FTL |
| Mar 20, 2015 | K142711 | ONFLEX Mesh C.R. Bard, Inc. | FTL |
| Mar 13, 2015 | K143386 | Progrip Laparoscopic Self-Fixating Mesh Sofradim Production, FR | FTL |
| Dec 31, 2014 | K142611 | TYRX Neuro Absorbable Antibacterial Envelope Medtronic Tyrx, Inc. | FTL |
| Nov 14, 2014 | K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: P Sofradim Production, FR | FTL |
| Oct 28, 2014 | K142900 | Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plu Sofradim Production, FR | FTL |
| Oct 23, 2014 | K141560 | ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE ETHICON, Inc. | FTL |
| Oct 17, 2014 | K142091 | PARIETENE MACROPOROUS MESH Sofradim Production | FTL |
| Sep 4, 2014 | K133889 | PREMIUM Cousin Biotech Sas, FR | FTL |
| Aug 6, 2014 | K141394 | X-REPAIR Synthasome | FTL |
| Jul 2, 2014 | K141499 | X-REPAIRSL Synthasome, Inc. | FTL |
| Jun 10, 2014 | K140967 | FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK Insightra Medical | FTL |
| May 30, 2014 | K133198 | ULTRAPRO COMFORT PLUG ETHICON, Inc. | FTL |
| May 7, 2014 | K140941 | PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH Sofradim Production | FTL |
| Dec 13, 2013 | K132441 | BARD VENTRALEX HERNIA PATCH C.R. Bard, Inc. | FTL |
| Nov 26, 2013 | K132699 | AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) Tyrx, Inc. | FTL |
| Oct 25, 2013 | K130428 | COVAMESH Biomup S.A., FR | FTL |
| Oct 23, 2013 | K131530 | DYNAMESH -CICAT Feg Textiltechnik Forschungs-Und Entwicklungsgesel, GB | FTL |
| Aug 22, 2013 | K131969 | SYMBOTEX(TM) COMPOSITE MESH Sofradim Production | FTL |
| Jul 10, 2013 | K131007 | AIGIS RX N MEDIUM; AIGIS RX N LARGE Tyrx, Inc. | FTL |
| May 20, 2013 | K130943 | AIGIS RX R PM/ AIGIS RX R ICD Tyrx, Inc. | FTL |
| May 1, 2013 | K130968 | VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM C.R. Bard, Inc. | FTL |
| Dec 13, 2012 | K120844 | MEDLINX SURGICAL MESH Medlinx Acala Pte, Ltd. | FTL |
| Dec 11, 2012 | K123479 | PROGRIP LAPAROSCOPIC SELF-FIXATING MESH Sofradim Production | FTL |
| Nov 2, 2012 | K122436 | COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM C.R. Bard, Inc. | FTL |
| Aug 23, 2012 | K113552 | FREEDOM INGUINAL HERNIA IMPLANT Insightra Medical | FTL |
| Jul 20, 2012 | K113229 | VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING C.R. Bard, Inc. | FTL |
| Jul 17, 2012 | K113311 | TIO2MESH TM Biocer Entwicklungs GmbH | FTL |
| Jun 29, 2012 | K120897 | PROGRIP LAPARSCOPIC SELF-FIXATING MESH Sofradim Production | FTL |
| Jun 26, 2012 | K120025 | SURGIMESH XB - SKIRTED Aspide Medical | FTL |
| Jun 13, 2012 | K120506 | PARIETEX COMPOSITE VENTRAL PATCH Sofradim Production | FTL |
| Apr 26, 2012 | K121070 | C-QUR RPM MESH Atrium Medical Corp. | FTL |
| Apr 2, 2012 | K111695 | HYBRID GRAFT Cook Biotech, Inc. | FTL |
| Jan 25, 2012 | K111337 | TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD Tornier, Inc. | FTL |
| Dec 23, 2011 | K112567 | BIOMERIX ASSURE Biomerix Corporation | FTL |
| Dec 23, 2011 | K112499 | BIOMERIX COMPOSITE SURGICAL MESH Biomerix Corporation | FTL |
| Nov 22, 2011 | K112784 | RENASYS AB ABOMINAL DRESSING KIT Smith & Nephew, Inc. | FTL |
| Aug 11, 2011 | K110663 | PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES) Sofradim Production | FTL |
| Jun 14, 2011 | K100313 | HYDROFIX SURGICAL SHEET Mimedx Group, Inc. | FTL |
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