W.L. Gore & Associates, Inc. - FDA 510(k) Cleared Devices
163
Total
148
Cleared
0
Denied
163 devices
Cleared
Sep 05, 1996
MINI FLEX COIL
Radiology
132d
Cleared
Sep 03, 1996
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
General & Plastic Surgery
74d
Cleared
Aug 22, 1996
GORE SPHEREX IMPLANT
Ophthalmic
72d
Cleared
Aug 14, 1996
GORE BURR HOLE COVER
Neurology
181d
Cleared
Jul 31, 1996
PRECLUDE SYNBLOC MEMBRANE
Neurology
83d
Cleared
Jun 19, 1996
SAM FACIAL IMPLANT
General & Plastic Surgery
83d
Cleared
May 23, 1996
PRECLUDE IMA SLEEVE
Cardiovascular
106d
Cleared
May 15, 1996
DIASTAT VASCULAR ACCESS GRAFT
Cardiovascular
162d
Cleared
Apr 15, 1996
GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS
Dental
84d
Cleared
Mar 11, 1996
DIASTAT VASCULAR ACCESS GRAFT
Cardiovascular
97d
Cleared
Feb 01, 1996
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
General & Plastic Surgery
71d
Cleared
Jan 24, 1996
GORE-TEX DUALMESH BIOMATERIAL WITH HOLES
General & Plastic Surgery
54d
Cleared
Nov 14, 1995
GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
General & Plastic Surgery
144d
Cleared
Nov 01, 1995
PRECLUDE DURA SUBSTITUTE
Neurology
71d
Cleared
Oct 07, 1995
GORE-TEX MYCROMESH BIOMATERIAL
General & Plastic Surgery
179d
Cleared
Oct 07, 1995
GORE-TEX DUALMESH BIOMATERIAL
General & Plastic Surgery
179d
Cleared
Oct 07, 1995
GORE-TEX SOFT TISSUE PATCH
General & Plastic Surgery
178d
Cleared
Oct 06, 1995
DIASTAT VASCULAR ACCESS GRAFT
Cardiovascular
85d
Cleared
Oct 06, 1995
DIASTAT VASCULAR ACCESS GRAFT
Cardiovascular
84d
Cleared
Jun 01, 1995
GORE SMOOTHER GUIDED RASP
Orthopedic
79d
Cleared
Apr 24, 1995
GORE-TEX DUALMESH PLUS BIOMATERIAL
General & Plastic Surgery
131d
Cleared
Apr 24, 1995
GORE-TEX MYCROMESH PLUS BIOMATERIAL
General & Plastic Surgery
131d
Cleared
Mar 28, 1995
RESOLUT REGENERATIVE MATERIAL
Dental
652d
Cleared
Mar 22, 1995
GORE-TEX SAM FACIAL IMPLANT
General & Plastic Surgery
89d
Cleared
Mar 03, 1995
GORE LAPAROSCOPIC SUTURE PASSER (NON-STERILE)
General & Plastic Surgery
87d
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