Sofradim Production - FDA 510(k) Cleared Devices
41
Total
41
Cleared
0
Denied
37 devices
Cleared
May 05, 2010
PARIE TENE PROGRIP MESH
General & Plastic Surgery
7d
Cleared
May 06, 2009
PARIETEX MONOFILAMENT POLYESTER MESH
General & Plastic Surgery
37d
Cleared
Aug 13, 2008
PARIETEX COMPOSITE MONO PM MESH
General & Plastic Surgery
114d
Cleared
May 28, 2008
PARIETEX PROGRIP MESH
General & Plastic Surgery
44d
Cleared
Mar 13, 2008
PREVADH MESH
General & Plastic Surgery
113d
Cleared
Jul 10, 2007
PARIETEX POLYESTER MESH WITH INTRODUCER
General & Plastic Surgery
26d
Cleared
Feb 18, 2005
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
General & Plastic Surgery
22d
Cleared
Apr 29, 2004
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
General & Plastic Surgery
10d
Cleared
Jan 15, 2004
UGYTEX MESH
General & Plastic Surgery
85d
Cleared
Oct 22, 2003
PARIEFIX
General & Plastic Surgery
107d
Cleared
Jan 24, 2001
SOFRADIM PARIETEX SURGICAL MESHES
General & Plastic Surgery
29d
Cleared
Jul 12, 1999
PARIETENE POLYPROPYLENE MESH
General & Plastic Surgery
81d