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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)
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Top companies in FTL

Company510(k)sRecalls
W. L. Gore & Associates, Inc.371
Sofradim Production361
ETHICON, Inc.253
C. R. Bard260
Davol Inc., Sub. C. R. Bard, Inc.817
Atrium Medical Corp.145
Davol, Inc.44
Tyrx, Inc.53
American Medical Systems, Inc.34
Covidien15
Decided510(k)Device and applicantCode
May 13, 2011K111121VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
Proxy Biomedical , Ltd.
FTL
May 10, 2011K102788TORNIER BIOFIBER SCAFFOLD
Tornier, Inc.
FTL
Apr 19, 2011K110816PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
Sofradim Production
FTL
Apr 19, 2011K110815PARIETEX OPTIMIZED COMPOSTIE MESH
Sofradim Production
FTL
Apr 1, 2011K110820VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
C.R. Bard, Inc.
FTL
Mar 23, 2011K101928VENTRALEX ST HERNIA PATCH
C.R. Bard, Inc.
FTL
Mar 23, 2011K101920VENTRIO ST HERNIA PATCH
C.R. Bard, Inc.
FTL
Mar 4, 2011K103682PARIETEX PROGRIP
Sofradim Production
FTL
Feb 22, 2011K103445ALACER SURGICAL SCAFFOLD
Alacer Biomedical, Inc.
FTL
Feb 15, 2011K110110ATRIUM CENTRILFX MESH
Atrium Medical Corporation
FTL
Dec 22, 2010K103568RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH
Coloplast A/S
FTL
Dec 16, 2010K102766COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
C.R. Bard, Inc.
FTL
Nov 5, 2010K101519PARIETEX PLUG AND PATCH
Sofradim Production
FTL
Sep 17, 2010K100787RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
Smith & Nephew, Inc.
FTL
Aug 16, 2010K101462ASCEND BLUE AC MESH; ASCEND BLUE PC MESH
Caldera Medical, Inc.
FTL
Jul 15, 2010K101851VENTRALIGHT ST MESH
Davol Inc., Sub. C. R. Bard, Inc.
FTL
Jun 25, 2010K093196BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
Cousin Biotech Sas, FR
FTL
Jun 25, 2010K092233SURGIMESH XD
Aspide Medical
FTL
May 13, 2010K093123BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
Biomerix Corporation
FTL
May 5, 2010K101197PARIE TENE PROGRIP MESH
Sofradim Production
FTL
Apr 22, 2010K093799TORNIER SURGICAL MESH
Tornier, Inc.
FTL
Apr 21, 2010K100229VENTRIO HERNIA PATCH
C.R. Bard, Inc.
FTL
Apr 9, 2010K093932ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH
Ethicon GmbH
FTL
Mar 26, 2010K093524PIVIT A/B ST AND PIVIT A/B ST-R
Tyrx, Inc.
FTL
Mar 5, 2010K092538REFINE SUPPORT SYSTEM, MODEL 100.0100
Alure Medical, Inc.
FTL
Jan 26, 2010K100076ATRIUM C-QUR OVT MESH
Atrium Medical Corp.
FTL
Jan 25, 2010K092224TIGR SURGICAL MESH , MODEL WK-6
Novus Scientific Pte, Ltd., SG
FTL
Jan 14, 2010K090271HYDROCOAT MESH
Promethean Surgical Devices, Inc.
FTL
Dec 8, 2009K092032BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160
Davol Inc., Sub. C. R. Bard, Inc.
FTL
Dec 7, 2009K093166WITTMANN PATCH
Aperta, LLC
FTL
Aug 3, 2009K091659BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
C.R. Bard, Inc.
FTL
Jun 4, 2009K090909C-QUR V -PATCH MESH
Atrium Medical Corp.
FTL
Jun 2, 2009K090934PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
American Medical Systems, Inc.
FTL
May 14, 2009K090489ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
Kci USA, Inc.
FTL
May 11, 2009K083102REFINE LIFT SYSTEM
Alure Medical, Inc.
FTL
May 6, 2009K090858PARIETEX MONOFILAMENT POLYESTER MESH
Sofradim Production
FTL
May 5, 2009K090288ORTHADAPT PR
Pegasus Biologics, Inc.
FTL
Apr 23, 2009K083467REBOUND HRDV
Minnesota Medical Development, Inc.
FTL
Mar 27, 2009K083307SYNTHASOME X-REPAIR
Synthasome, Inc.
FTL
Mar 27, 2009K083266GORE BIO-A FISTULA PLUG
W. L. Gore & Associates, Inc.
FTL
Jan 15, 2009K081377NUVASIVE SURGICAL MESH SYSTEM
Nuvasive, Inc.
FTL
Jan 14, 2009K082748ATRIUM PROLITE S MESH
Atrium Medical Corp.
FTL
Jan 7, 2009K082941BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
Biomerix Corporation
FTL
Nov 13, 2008K080442SERISCAFFOLD SURGICAL MESH
Serica Technologies, Inc.
FTL
Oct 7, 2008K081010BARD 3DMAX MESH
Davol Inc., Sub. C. R. Bard, Inc.
FTL
Sep 29, 2008K081777VENTRIO HERNIA PATCH
C.R. Bard, Inc.
FTL
Sep 15, 2008K080216SUPRAMESH EXTRA
S. Jackson, Inc.
FTL
Sep 5, 2008K082216TBD ETHICON MESH
ETHICON, Inc.
FTL
Aug 18, 2008K073579DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN
Feg Textiltechnik Forschungs-Und Entwicklungsgesel, GB
FTL
Aug 18, 2008K072974SURGIMESH XB
Aspide Medical
FTL

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