Medical Device Manufacturer · US , Mchenry , IL

W.L. Gore & Associates, Inc. - FDA 510(k) Cleared Devices

163 submissions · 148 cleared · Since 1980

Official Website

163

Total

148

Cleared

0

Denied

163 devices

126-150 of 163

Cleared Jun 03, 1992

GORE TUNNELER, MODIFICATION

Cardiovascular · 93d

Cleared May 29, 1992

PROCEL BURN COVER

General & Plastic Surgery · 158d

Cleared Feb 14, 1992

SURGICAL APPAREL

General Hospital · 112d

Cleared Jan 16, 1992

CANNULATED DRILL BIT

Orthopedic · 24d

Cleared Dec 04, 1991

GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE

General & Plastic Surgery · 61d

Cleared Nov 05, 1991

GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE

Cardiovascular · 32d

Cleared Nov 05, 1991

GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE

Cardiovascular · 32d

Cleared Nov 05, 1991

GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE

Cardiovascular · 32d

Cleared Oct 11, 1991

GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM

Cardiovascular · 151d

Cleared Sep 30, 1991

Cleared Mar 26, 1991

GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE

Cardiovascular · 50d

Cleared Jan 16, 1991

BIFURCATED GORE TEX STRETCH VASCULAR GRAFT

Cardiovascular · 120d

Cleared Dec 06, 1990

GORE-TEX(R) STRETCH VASCULAR GRAFT

Cardiovascular · 104d

Cleared Sep 05, 1990

AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT

Cardiovascular · 149d

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 Nov 22, 1988

Orthopedic · 85d

Cleared May 18, 1988

GORE-TEX VASCULAR GRAFT

Cardiovascular · 120d

Cleared May 18, 1988

GORE-TEX VASCULAR GRAFT

Cardiovascular · 26d

Cleared Sep 02, 1986

2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP

Orthopedic · 49d

Cleared May 19, 1986

GORE-TEX PERIODONTAL MATERIAL

Cleared Jun 28, 1985

GORE-TEX TISSUE MATRIX

General & Plastic Surgery · 248d

Cleared Jan 24, 1985

GORE-TEX TUNNELER

Cardiovascular · 62d

Cleared Oct 01, 1984

GORE-TEX VASCULAR GRAFT, FEP-RINGED

Cardiovascular · 124d

Cleared Jun 01, 1984

GORE-TEX CATHETER

Gastroenterology & Urology · 95d

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