Medical Device Manufacturer · US , Mchenry , IL

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

163 submissions · 148 cleared · Since 1980

163

Total

148

Cleared

0

Denied

62 devices

51-62 of 62

Cleared May 18, 1988

GORE-TEX VASCULAR GRAFT

Cardiovascular · 120d

Cleared May 18, 1988

GORE-TEX VASCULAR GRAFT

Cardiovascular · 26d

Cleared Jan 24, 1985

GORE-TEX TUNNELER

Cardiovascular · 62d

Cleared Oct 01, 1984

GORE-TEX VASCULAR GRAFT, FEP-RINGED

Cardiovascular · 124d

Cleared Jan 06, 1984

GORE-TEX SURGICAL MEMBRANE

Cardiovascular · 302d

Cleared Aug 13, 1983

VASCULAR GRAFT/BIFURCATED/FEP-RINGED

Cardiovascular · 152d

Cleared Jan 12, 1983

GORE-TES EXPANDED PTFE PATCH

Cardiovascular · 216d

Cleared Dec 29, 1982

FEP-RINGED GORE-TEX@ VASCULAR GRAFT

Cardiovascular · 190d

Cleared May 18, 1982

FED RINGED-TEX VASCULAR GRAFT

Cardiovascular · 21d

Cleared Sep 16, 1981

GORE-TEX CARDIOVASCULAR PATCH

Cardiovascular · 77d

Cleared Aug 20, 1981

GORE-TEX VASULAR GRAFT

Cardiovascular · 85d

Cleared Oct 10, 1980

GORE-TEX VASCULAR GRAFT

Cardiovascular · 38d