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 30, 2020
T-Line Hernia Mesh
Deep Blue Medical Advances, Inc.
General & Plastic Surgery
138d
Cleared
Mar 27, 2020
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
Medtronic, Inc.
General & Plastic Surgery
206d
Cleared
Dec 06, 2019
Dextile Anatomical Mesh
Sofradim Production
General & Plastic Surgery
91d
Cleared
Oct 22, 2019
VICRYL Mesh
Ethicon, Inc.
General & Plastic Surgery
152d
Cleared
Sep 27, 2019
FlexBand Plus
International Life Sciences
General & Plastic Surgery
53d
Cleared
Sep 26, 2019
Exogenesis Hernia Mesh
Exogenesis Corporation
General & Plastic Surgery
107d
Cleared
Dec 14, 2018
Phasix ST Mesh with Echo 2 Positioning System
C.R. Bard, Inc.
General & Plastic Surgery
140d
Cleared
Dec 04, 2018
Endoform Reconstructive Template - Non Absorbable
Aroa Biosurgery , Ltd.
General & Plastic Surgery
138d
Cleared
Oct 31, 2018
DynaMesh-POSTERIOR
Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft
General & Plastic Surgery
90d
Cleared
Aug 02, 2018
Polydioxanone Surgical Scaffold
Lntegra Lifesciences
General & Plastic Surgery
99d
Cleared
Jul 26, 2018
PROLENE (Polypropylene) 3D Patch
Ethicon, Inc.
General & Plastic Surgery
73d
Cleared
Jul 02, 2018
ULTRAPRO Mesh and ULTRAPRO ADVANCED
Ethicon, Inc.
General & Plastic Surgery
87d
Cleared
Jun 28, 2018
PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
Ethicon, Inc.
General & Plastic Surgery
90d
Cleared
Jun 07, 2018
TYRX Neuro Absorbable Antibacterial Envelope (medium)
Medtronic, Inc.
General & Plastic Surgery
142d
Cleared
Apr 30, 2018
VitaMESH Macroporous PP Surgical Mesh
Proxy Biomedical , Ltd.
General & Plastic Surgery
241d
Cleared
Apr 24, 2018
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
Medtronic, Inc.
General & Plastic Surgery
111d
Cleared
Mar 09, 2018
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
Sofradim Production
General & Plastic Surgery
85d
Cleared
Feb 01, 2018
Duatene bilayer mesh
Sofradim Production
General & Plastic Surgery
177d
Cleared
Oct 05, 2017
PROLENE Soft Polypropylene Mesh
Ethicon, Inc.
General & Plastic Surgery
86d
Cleared
May 11, 2017
GORE SYNECOR Preperitoneal Biomaterial
W.L. Gore & Associates, Inc.
General & Plastic Surgery
143d
Cleared
Mar 11, 2017
PROLENE Soft Polypropylene Mesh
Ethicon, Inc.
General & Plastic Surgery
121d
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
Sep 18, 2015
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
C.R. Bard, Inc.
General & Plastic Surgery
261d
Cleared
Mar 25, 2015
Modified ONFLEX Mesh
C.R. Bard, Inc.
General & Plastic Surgery
184d