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
Jul 26, 2006
TRULENE MESH
Sutures India Pvt., Ltd.
General & Plastic Surgery
203d
Cleared
Jul 19, 2006
OPTILENE MESH
Aesculap, Inc.
General & Plastic Surgery
33d
Cleared
Jul 17, 2006
SURGICAL MESH SYSTEM
Nuvasive, Inc.
General & Plastic Surgery
242d
Cleared
Jul 14, 2006
TYRX ANTIMICROBIAL MESH
Tyrx Pharma, Inc.
General & Plastic Surgery
196d
Cleared
Jun 02, 2006
BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery
22d
Cleared
May 25, 2006
PROCEED SURGICAL MESH
Ethicon, Inc.
General & Plastic Surgery
69d
Cleared
Mar 31, 2006
ATRIUM MEDICAL CORPORATION C-QUR MESH
Atrium Medical Corp.
General & Plastic Surgery
416d
Cleared
Mar 28, 2006
VITAMESH MACROPOROUS PP SURGICAL MESH
Proxy Biomedical , Ltd.
General & Plastic Surgery
29d
Cleared
Feb 22, 2006
POPMESH
Caldera Medical, Inc.
General & Plastic Surgery
76d
Cleared
Feb 22, 2006
CALDERA MESH
Caldera Medical, Inc.
General & Plastic Surgery
50d
Cleared
Jan 19, 2006
SPORTMESH
Artimplant AB
General & Plastic Surgery
106d
Cleared
Jan 18, 2006
OPTILENE MESH LP
Aesculap, Inc.
General & Plastic Surgery
65d
Cleared
Dec 22, 2005
TYRX SURGICAL MESH, MODEL SMPC-0501
Tyrx Pharma, Inc.
General & Plastic Surgery
72d
Cleared
Dec 19, 2005
SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
Genzyme Corporation
General & Plastic Surgery
48d
Cleared
Dec 07, 2005
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
W.L. Gore & Associates, Inc.
General & Plastic Surgery
21d
Cleared
Dec 07, 2005
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
W.L. Gore & Associates
General & Plastic Surgery
21d
Cleared
Oct 20, 2005
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
C.R. Bard, Inc.
General & Plastic Surgery
73d
Cleared
Sep 29, 2005
VICRYL * MESH BAG
Ethicon, Inc.
General & Plastic Surgery
97d
Cleared
Aug 18, 2005
INCLOSE SURGICAL MESH SYSTEM
Anulex Technologies, Inc.
General & Plastic Surgery
122d
Cleared
Aug 11, 2005
ORTHOMEND
Tei Biosciences, Inc.
General & Plastic Surgery
42d
Cleared
Aug 11, 2005
MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH
Proxy Biomedical , Ltd.
General & Plastic Surgery
8d
Cleared
May 27, 2005
SURGI-WRAP MAST BIORESORBABLE SHEET
Mast Biosurgery USA, Inc.
General & Plastic Surgery
106d
Cleared
May 20, 2005
MOTIFMESH SOFT TISSUE PATCH
Proxy Biomedical , Ltd.
General & Plastic Surgery
65d
Cleared
May 16, 2005
REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH
Angiologica B. M. Srl
General & Plastic Surgery
180d