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 W.L. Gore & Associates, Inc., Sofradim Production and C.R. Bard, Inc..
336
Total
336
Cleared
118d
Avg days
1979
Since
336 devices
Cleared
May 30, 2014
ULTRAPRO COMFORT PLUG
Ethicon, Inc.
General & Plastic Surgery
225d
Cleared
May 07, 2014
PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
Sofradim Production
General & Plastic Surgery
23d
Cleared
Dec 13, 2013
BARD VENTRALEX HERNIA PATCH
C.R. Bard, Inc.
General & Plastic Surgery
129d
Cleared
Nov 26, 2013
AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)
Tyrx, Inc.
General & Plastic Surgery
89d
Cleared
Oct 25, 2013
COVAMESH
Biomup S.A.
General & Plastic Surgery
247d
Cleared
Oct 23, 2013
DYNAMESH -CICAT
Feg Textiltechnik Forschungs-Und Entwicklungsgesel
General & Plastic Surgery
148d
Cleared
Aug 22, 2013
SYMBOTEX(TM) COMPOSITE MESH
Sofradim Production
General & Plastic Surgery
55d
Cleared
Jul 10, 2013
AIGIS RX N MEDIUM
Tyrx, Inc.
General & Plastic Surgery
90d
Cleared
May 20, 2013
AIGIS RX R PM/ AIGIS RX R ICD
Tyrx, Inc.
General & Plastic Surgery
46d
Cleared
May 01, 2013
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
C.R. Bard, Inc.
General & Plastic Surgery
23d
Cleared
Dec 13, 2012
MEDLINX SURGICAL MESH
Medlinx Acala Pte, Ltd.
General & Plastic Surgery
268d
Cleared
Dec 11, 2012
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
Sofradim Production
General & Plastic Surgery
28d
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
Aug 23, 2012
FREEDOM INGUINAL HERNIA IMPLANT
Insightra Medical
General & Plastic Surgery
266d
Cleared
Jul 20, 2012
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
C.R. Bard, Inc.
General & Plastic Surgery
261d
Cleared
Jul 17, 2012
TIO2MESH TM
Biocer Entwicklungs GmbH
General & Plastic Surgery
251d
Cleared
Jun 29, 2012
PROGRIP LAPARSCOPIC SELF-FIXATING MESH
Sofradim Production
General & Plastic Surgery
95d
Cleared
Jun 26, 2012
SURGIMESH XB - SKIRTED
Aspide Medical
General & Plastic Surgery
175d
Cleared
Jun 13, 2012
PARIETEX COMPOSITE VENTRAL PATCH
Sofradim Production
General & Plastic Surgery
113d
Cleared
Apr 26, 2012
C-QUR RPM MESH
Atrium Medical Corp.
General & Plastic Surgery
17d
Cleared
Apr 02, 2012
HYBRID GRAFT
Cook Biotech, Inc.
General & Plastic Surgery
291d
Cleared
Jan 25, 2012
TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
Tornier, Inc.
General & Plastic Surgery
258d
Cleared
Dec 23, 2011
BIOMERIX COMPOSITE SURGICAL MESH
Biomerix Corporation
General & Plastic Surgery
115d
Cleared
Dec 23, 2011
BIOMERIX ASSURE
Biomerix Corporation
General & Plastic Surgery
112d