Medical Device Manufacturer · US , Ayer , MA

Sofradim Production - FDA 510(k) Cleared Devices

42 submissions · 42 cleared · Since 1999

42

Total

42

Cleared

0

Denied

38 devices

26-38 of 38

Cleared Nov 05, 2010

PARIETEX PLUG AND PATCH

General & Plastic Surgery · 156d

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

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

General & Plastic Surgery · 85d

Cleared Oct 22, 2003

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