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

FDA 510(k) cleared devices by W.L. Gore & Associates, Inc. Orthopedic ✕

7 devices

1-7 of 7

Cleared Jun 01, 1995

GORE SMOOTHER GUIDED RASP

Orthopedic · 79d

Cleared May 19, 1994

GORE SMOOTHER II AND GORE BPTB

Orthopedic · 64d

Cleared Mar 23, 1994

GORE SMOOTHER CRUCIAL TOOL

Orthopedic · 84d

Cleared Jan 16, 1992

CANNULATED DRILL BIT

Orthopedic · 24d

Cleared Nov 22, 1988

Orthopedic · 85d

Cleared Sep 02, 1986

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

Orthopedic · 49d

Cleared Aug 12, 1983

Orthopedic · 60d