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. General & Plastic Surgery ✕

6 devices

1-6 of 6

Cleared Dec 15, 2014

ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE

General & Plastic Surgery · 283d

Cleared May 22, 2013

H-30 HOLMIUM LASER SYSTEM

General & Plastic Surgery · 90d

Cleared Sep 06, 2001

LIVER TAMPONADE BALLOON

General & Plastic Surgery · 203d

Cleared Apr 11, 1994

MURDOCH LAPAROSCOPE LENS CLEANER

General & Plastic Surgery · 34d

Cleared Jan 10, 1994

GIANTURCO-HELFRICH HERNIS MESH

General & Plastic Surgery · 266d

Cleared Dec 18, 1991

GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT

General & Plastic Surgery · 1009d