W.L. Gore & Associates, Inc. - FDA 510(k) Cleared Devices
163
Total
148
Cleared
0
Denied
61 devices
Cleared
Jan 28, 1994
GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH
General & Plastic Surgery
345d
Cleared
Nov 29, 1993
GORE-TEK(R) SOFT TISSUE PATCH
General & Plastic Surgery
335d
Cleared
Oct 29, 1993
GORE-TEX MICRO MESH
General & Plastic Surgery
234d
Cleared
Sep 09, 1993
GORE-TEX(TM) DUAL MESH
General & Plastic Surgery
252d
Cleared
May 29, 1992
PROCEL BURN COVER
General & Plastic Surgery
158d
Cleared
Dec 04, 1991
GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE
General & Plastic Surgery
61d
Cleared
Mar 13, 1990
MODIFIED GORE-TEX SURGICAL TAPE
General & Plastic Surgery
61d
Cleared
Oct 10, 1989
GORE-TEX SURGICAL TAPE
General & Plastic Surgery
78d
Cleared
Jun 28, 1985
GORE-TEX TISSUE MATRIX
General & Plastic Surgery
248d
Cleared
Jan 10, 1984
STERILIZATION OF GORE-TEX SOFT TISSU
General & Plastic Surgery
76d
Cleared
Mar 26, 1982
GORE-TEX TISSUE REINFORCEMENT PATCH
General & Plastic Surgery
60d