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 C.R. Bard, Inc., Sofradim Production and Ethicon, Inc..
336
Total
336
Cleared
118d
Avg days
1979
Since
336 devices
Cleared
Mar 20, 2015
ONFLEX Mesh
C.R. Bard, Inc.
General & Plastic Surgery
179d
Cleared
Dec 13, 2013
BARD VENTRALEX HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
129d
Cleared
May 01, 2013
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
C.R. Bard, Inc.
General & Plastic Surgery
23d
Cleared
Nov 02, 2012
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
C.R. Bard, Inc.
General & Plastic Surgery
84d
Cleared
Jul 20, 2012
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
C.R. Bard, Inc.
General & Plastic Surgery
261d
Cleared
Nov 22, 2011
RENASYS AB ABOMINAL DRESSING KIT
Smith & Nephew, Inc.
General & Plastic Surgery
57d
Cleared
Apr 01, 2011
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
C.R. Bard, Inc.
General & Plastic Surgery
9d
Cleared
Mar 23, 2011
VENTRIO ST HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
257d
Cleared
Mar 23, 2011
VENTRALEX ST HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
257d
Cleared
Dec 16, 2010
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
C.R. Bard, Inc.
General & Plastic Surgery
83d
Cleared
Sep 17, 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
Smith & Nephew, Inc.
General & Plastic Surgery
182d
Cleared
Apr 21, 2010
VENTRIO HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
85d
Cleared
Aug 03, 2009
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
C.R. Bard, Inc.
General & Plastic Surgery
55d
Cleared
Sep 29, 2008
VENTRIO HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
98d
Cleared
Oct 20, 2005
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
C.R. Bard, Inc.
General & Plastic Surgery
73d
Cleared
Sep 10, 2004
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
C.R. Bard, Inc.
General & Plastic Surgery
44d
Cleared
Mar 01, 2004
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
C.R. Bard, Inc.
General & Plastic Surgery
83d
Cleared
Feb 20, 2003
SMALL BARD VENTRALEX PATCH
C.R. Bard, Inc.
General & Plastic Surgery
78d
Cleared
Aug 23, 2002
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
C.R. Bard, Inc.
General & Plastic Surgery
35d
Cleared
Jul 16, 2002
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
C.R. Bard, Inc.
General & Plastic Surgery
49d
Cleared
Apr 04, 2001
IVS TUNNELLER
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery
90d
Cleared
Oct 11, 2000
COMPOSIX E/X MESH
C.R. Bard, Inc.
General & Plastic Surgery
44d
Cleared
Nov 06, 1998
MESH, SURGICAL, POLYMERIC
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery
105d
Cleared
Nov 15, 1996
SURGICAL FABRICS
Boston Scientific Corp
General & Plastic Surgery
88d