Medical Device Manufacturer · US , Mchenry , IL

Cook, Inc. - FDA 510(k) Cleared Devices

190 submissions · 179 cleared · Since 1976

190

Total

179

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cook, Inc. Radiology ✕

14 devices

1-14 of 14

Cleared May 27, 1999

GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER

Radiology · 80d

Cleared Nov 03, 1998

VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER

Radiology · 158d

Cleared Aug 17, 1994

COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH

Radiology · 191d

Cleared Sep 20, 1993

CHENOWETH-FRANK RADIOPATHOLOGICAL GRID

Radiology · 48d

Cleared Apr 13, 1993

HIGH DOSE RATE REMOTE AFTERLOADING CATHETER

Radiology · 260d

Cleared Jan 26, 1993

MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER

Radiology · 203d

Cleared Nov 27, 1992

BODY BAND RESTRAINT STRAP SET

Radiology · 155d

Cleared Sep 23, 1992

WRIST RESTRAINT FOR GE9800 C.T. TABLES

Radiology · 90d

Cleared Sep 23, 1992

ADULT CHIN STRAP FOR CT TABLES

Radiology · 90d

Cleared Sep 23, 1992

Radiology · 90d

Cleared Sep 23, 1992

ARM EXTENDER FOR CT TABLES

Radiology · 90d

Cleared Sep 23, 1992

Radiology · 90d

Cleared Sep 23, 1992

HEAD RESTRAINT FOR CT TABLES

Radiology · 90d

Cleared Sep 11, 1992

Radiology · 78d