FDA Product Code FTL: Mesh, Surgical, Polymeric
Surgical mesh has transformed the repair of abdominal wall defects. FDA product code FTL covers polymeric surgical mesh used for tissue reinforcement and repair.
These woven or knitted synthetic materials — typically polypropylene or polyester — provide structural support to weakened or deficient tissue in hernia repair, pelvic floor reconstruction, and other procedures where native tissue alone is insufficient for durable closure.
FTL devices are Class II medical devices, regulated under 21 CFR 878.3300 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Sofradim Production, W.L. Gore & Associates, Inc. and C.R. Bard, Inc..
337
Total
337
Cleared
119d
Avg days
1979
Since
337 devices
Cleared
Apr 22, 2010
TORNIER SURGICAL MESH
Tornier, Inc.
General & Plastic Surgery
133d
Cleared
Apr 21, 2010
VENTRIO HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
85d
Cleared
Apr 09, 2010
ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH
Ethicon GmbH
General & Plastic Surgery
108d
Cleared
Mar 26, 2010
PIVIT A/B ST AND PIVIT A/B ST-R
Tyrx, Inc.
General & Plastic Surgery
130d
Cleared
Mar 05, 2010
REFINE SUPPORT SYSTEM, MODEL 100.0100
Alure Medical, Inc.
General & Plastic Surgery
198d
Cleared
Jan 26, 2010
ATRIUM C-QUR OVT MESH
Atrium Medical Corp.
General & Plastic Surgery
14d
Cleared
Jan 25, 2010
TIGR SURGICAL MESH , MODEL WK-6
Novus Scientific Pte, Ltd.
General & Plastic Surgery
186d
Cleared
Jan 14, 2010
HYDROCOAT MESH
Promethean Surgical Devices, Inc.
General & Plastic Surgery
344d
Cleared
Dec 08, 2009
BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery
155d
Cleared
Dec 07, 2009
WITTMANN PATCH
Aperta, LLC
General & Plastic Surgery
62d
Cleared
Aug 03, 2009
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
C.R. Bard, Inc.
General & Plastic Surgery
55d
Cleared
Jun 04, 2009
C-QUR V -PATCH MESH
Atrium Medical Corp.
General & Plastic Surgery
64d
Cleared
Jun 02, 2009
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
American Medical Systems, Inc.
General & Plastic Surgery
61d
Cleared
May 14, 2009
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
Kci USA, Inc.
General & Plastic Surgery
78d
Cleared
May 11, 2009
REFINE LIFT SYSTEM
Alure Medical, Inc.
General & Plastic Surgery
203d
Cleared
May 06, 2009
PARIETEX MONOFILAMENT POLYESTER MESH
Sofradim Production
General & Plastic Surgery
37d
Cleared
May 05, 2009
ORTHADAPT PR
Pegasus Biologics, Inc.
General & Plastic Surgery
89d
Cleared
Apr 23, 2009
REBOUND HRDV
Minnesota Medical Development, Inc.
General & Plastic Surgery
150d
Cleared
Mar 27, 2009
GORE BIO-A FISTULA PLUG
W.L. Gore & Associates, Inc.
General & Plastic Surgery
142d
Cleared
Mar 27, 2009
SYNTHASOME X-REPAIR
Synthasome, Inc.
General & Plastic Surgery
137d
Cleared
Jan 15, 2009
NUVASIVE SURGICAL MESH SYSTEM
Nuvasive, Inc.
General & Plastic Surgery
244d
Cleared
Jan 14, 2009
ATRIUM PROLITE S MESH
Atrium Medical Corp.
General & Plastic Surgery
117d
Cleared
Jan 07, 2009
BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
Biomerix Corporation
General & Plastic Surgery
97d
Cleared
Nov 13, 2008
SERISCAFFOLD SURGICAL MESH
Serica Technologies, Inc.
General & Plastic Surgery
268d