W.L. Gore & Associates, Inc. - FDA 510(k) Cleared Devices
163
Total
148
Cleared
0
Denied
163 devices
Cleared
Aug 28, 2008
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
Cardiovascular
10d
Cleared
May 30, 2008
GORE INFINIT MESH
General & Plastic Surgery
45d
Cleared
Jun 29, 2007
GORE BALLOON SHEATH
Cardiovascular
101d
Cleared
Apr 02, 2007
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
General & Plastic Surgery
25d
Cleared
Nov 28, 2006
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
General & Plastic Surgery
15d
Cleared
Nov 09, 2006
GORE PROPATEN VASCULAR GRAFT
Cardiovascular
104d
Cleared
Aug 07, 2006
GORE PRECLUDE VESSEL GUARD
Cardiovascular
49d
Cleared
Dec 07, 2005
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
General & Plastic Surgery
21d
Cleared
Jun 15, 2005
GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE,...
Dental
30d
Cleared
Dec 22, 2004
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
General & Plastic Surgery
47d
Cleared
Dec 22, 2004
GORE POLYPROPYLENE HERNIA MESH
General & Plastic Surgery
44d
Cleared
Jul 21, 2004
VIABIL BILIARY ENDOPROSTHESIS
Gastroenterology & Urology
54d
Cleared
May 05, 2004
GORE TRI-LOBE BALLOON CATHETER
Cardiovascular
163d
Cleared
Dec 31, 2003
GORE BIOABSORBABLE MESH
General & Plastic Surgery
37d
Cleared
Nov 28, 2003
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
General & Plastic Surgery
77d
Cleared
Aug 15, 2003
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
General & Plastic Surgery
30d
Cleared
Aug 13, 2003
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
Cardiovascular
41d
Cleared
May 08, 2003
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
Radiology
31d
Cleared
Apr 21, 2003
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
General & Plastic Surgery
41d
Cleared
Mar 07, 2003
VIATORR ENDOPROSTHESIS
General & Plastic Surgery
79d
Cleared
Dec 19, 2002
VIABIL BILIARY ENDOPROSTHESIS
Gastroenterology & Urology
363d
Cleared
Dec 10, 2002
MODIFICATION TO VIABAHN ENDOPROSTHESIS
General & Plastic Surgery
25d
Cleared
Nov 18, 2002
GORE 3.0T TORSO ARRAY
Radiology
17d
Cleared
Nov 08, 2002
PRECLUDE MVP DURA SUBSTITUTE
Neurology
184d
Cleared
Sep 10, 2002
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
General & Plastic Surgery
19d
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