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..
336
Total
336
Cleared
118d
Avg days
1979
Since
336 devices
Cleared
Dec 22, 2016
DynaMesh-VENTRAL
Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft
General & Plastic Surgery
202d
Cleared
Jun 16, 2016
Endoform Reconstructive Template
Aroa Biosurgery Limited (Formerly Mesynthes Limited)
General & Plastic Surgery
181d
Cleared
May 13, 2016
Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay
C.R. Bard, Inc.
General & Plastic Surgery
186d
Cleared
Dec 11, 2015
GORE SYNECOR Biomaterial
W.L. Gore & Associates, Inc.
General & Plastic Surgery
88d
Cleared
Nov 17, 2015
TYRX Neuro Antibacterial Envelope
Tyrx, Inc.
General & Plastic Surgery
60d
Cleared
Oct 22, 2015
C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
Atrium Medical Corporation
General & Plastic Surgery
149d
Cleared
Sep 18, 2015
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
C.R. Bard, Inc.
General & Plastic Surgery
261d
Cleared
Aug 27, 2015
ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
Atrium Medical Corporation
General & Plastic Surgery
90d
Cleared
Jul 24, 2015
ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh
Ehicon, Inc.
General & Plastic Surgery
112d
Cleared
May 26, 2015
Versatex Monofilament Mesh
Sofradim Production
General & Plastic Surgery
130d
Cleared
May 07, 2015
Insightra Freedom Ventral Hernia Repair System
Insightra Medical
General & Plastic Surgery
269d
Cleared
Mar 27, 2015
TYRX Neuro Absorbable Antibacterial Envelope
Medtronic Tyrx, Inc.
General & Plastic Surgery
49d
Cleared
Mar 25, 2015
Modified ONFLEX Mesh
C.R. Bard, Inc.
General & Plastic Surgery
184d
Cleared
Mar 20, 2015
ONFLEX Mesh
C.R. Bard, Inc.
General & Plastic Surgery
179d
Cleared
Mar 13, 2015
Progrip Laparoscopic Self-Fixating Mesh
Sofradim Production
General & Plastic Surgery
107d
Cleared
Dec 31, 2014
TYRX Neuro Absorbable Antibacterial Envelope
Medtronic Tyrx, Inc.
General & Plastic Surgery
106d
Cleared
Nov 14, 2014
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh
Sofradim Production
General & Plastic Surgery
39d
Cleared
Oct 28, 2014
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
Sofradim Production
General & Plastic Surgery
22d
Cleared
Oct 23, 2014
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
Ethicon, Inc.
General & Plastic Surgery
133d
Cleared
Oct 17, 2014
PARIETENE MACROPOROUS MESH
Sofradim Production
General & Plastic Surgery
77d
Cleared
Sep 04, 2014
PREMIUM
Cousin Biotech Sas
General & Plastic Surgery
258d
Cleared
Aug 06, 2014
X-REPAIR
Synthasome
General & Plastic Surgery
70d
Cleared
Jul 02, 2014
X-REPAIRSL
Synthasome, Inc.
General & Plastic Surgery
26d
Cleared
Jun 10, 2014
FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK
Insightra Medical
General & Plastic Surgery
57d