Sofradim Production

FDA 510(k) & PMA Approved Devices — 36 products

Total Devices36

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K253956	ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)	FTL	2026-05-21	View
510(k)	K250869	Parietene™ Macroporous Mesh (PPM5050 )	FTL	2025-04-23	View
510(k)	K243315	ProGrip™ Self-Gripping Polypropylene Mesh	FTL	2025-01-17	View
510(k)	K233661	Transorb™ Self-Gripping Resorbable Mesh	OWT	2024-02-13	View
510(k)	K232373	Progrip™ Self-Gripping Polypropylene Mesh	FTL	2024-01-18	View
510(k)	K223218	Parietene Macroporous Mesh	FTL	2022-12-02	View
510(k)	K220586	Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh	FTL	2022-06-22	View
510(k)	K192443	Dextile Anatomical Mesh	FTL	2019-12-06	View
510(k)	K173796	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)	FTL	2018-03-09	View
510(k)	K172395	Duatene bilayer mesh	FTL	2018-02-01	View
510(k)	K163212	Parietene DS Composite Mesh	FTL	2017-06-29	View
510(k)	K131969	SYMBOTEX(TM) COMPOSITE MESH	FTL	2013-08-22	View
510(k)	K123479	PROGRIP LAPAROSCOPIC SELF-FIXATING MESH	FTL	2012-12-11	View
510(k)	K120897	PROGRIP LAPARSCOPIC SELF-FIXATING MESH	FTL	2012-06-29	View
510(k)	K120506	PARIETEX COMPOSITE VENTRAL PATCH	FTL	2012-06-13	View
510(k)	K110663	PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)	FTL	2011-08-11	View
510(k)	K110815	PARIETEX OPTIMIZED COMPOSTIE MESH	FTL	2011-04-19	View
510(k)	K110816	PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)	FTL	2011-04-19	View
510(k)	K103682	PARIETEX PROGRIP	FTL	2011-03-04	View
510(k)	K101519	PARIETEX PLUG AND PATCH	FTL	2010-11-05	View