FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

190 results for "Cook, Inc."
97–120 of 190
Search insights Median review: 90d Cleared: 100% Top manufacturer: Cook, Inc. Lead specialty: Cardiovascular
Cleared Nov 24, 2000
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
K000651 · HCG
Cook, Inc.
Neurology · 270d
Cleared Oct 18, 2000
GUNTHER TULIP VENA CAVA MREYE FILTER SET
K000855 · DTK
Cook, Inc.
Cardiovascular · 216d
Cleared Jul 20, 2000
PTA BALLOON CATHETER
K001087 · LIT
Cook, Inc.
Cardiovascular · 107d
Cleared Jan 11, 2000
FLIPPER DETACHABLE EMBOLIZATION COIL
K993455 · KRD
Cook, Inc.
Cardiovascular · 90d
Cleared Dec 20, 1999
EMBOLIZATION COIL SYSTEM
K992121 · KRD
Cook, Inc.
Cardiovascular · 180d
Cleared Aug 27, 1999
URETHANE PICC LINE MODEL UPICS-
K992198 · FOZ
Cook, Inc.
General Hospital · 58d
Cleared Aug 20, 1999
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
K991985 · FPA
Cook, Inc.
General Hospital · 67d
Cleared May 27, 1999
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K990753 · JAQ
Cook, Inc.
Radiology · 80d
Cleared Apr 02, 1999
ENVY GUIDING CATHETER
K990726 · DQY
Cook, Inc.
Cardiovascular · 28d
Cleared Feb 12, 1999
MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY
K982333 · MSD
Cook, Inc.
Gastroenterology & Urology · 225d
Cleared Jan 27, 1999
CHAIT CECOSTOMY CATHETER
K982500 · KNT
Cook, Inc.
Gastroenterology & Urology · 191d
Cleared Jan 20, 1999
ROWE DUAL-CHECK VALVE
K983217 · FPA
Cook, Inc.
General Hospital · 128d
Cleared Nov 12, 1998
STRATEGY CORONARY WIRE GUIDE
K983771 · DQX
Cook, Inc.
Cardiovascular · 17d
Cleared Nov 03, 1998
VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K981886 · JAQ
Cook, Inc.
Radiology · 158d
Cleared Oct 16, 1998
ENVY GUIDING CATHETER
K974774 · DQO
Cook, Inc.
Cardiovascular · 298d
Cleared Aug 20, 1998
PTA BALLOON CATHETER
K980390 · LIT
Cook, Inc.
Cardiovascular · 199d
Cleared Jun 29, 1998
MODIFICATION FOR PTA BALLOON CATHETER
K981906 · LIT
Cook, Inc.
Cardiovascular · 28d
Cleared Apr 16, 1998
PTA BALLOON CATHETER
K972800 · LIT
Cook, Inc.
Cardiovascular · 262d
Cleared Nov 03, 1997
QUICK-CARE BIOPSY NEEDLE
K973565 · KNW
Cook, Inc.
Gastroenterology & Urology · 45d
Cleared Aug 29, 1997
BRONCHIAL BLOCKER
K962167 · CBI
Cook, Inc.
Anesthesiology · 450d
Cleared Jul 14, 1997
MRI NEEDLES
K963565 · FCG
Cook, Inc.
Gastroenterology & Urology · 312d
Cleared Nov 04, 1996
MICROFERRET CATHETER
K961668 · KRA
Cook, Inc.
Cardiovascular · 188d
Cleared Oct 11, 1996
REIGEL TUNNELING DEVICE
K962761 · GYK
Cook, Inc.
Neurology · 87d
Cleared Aug 29, 1996
VENTRICULAR CATHETER SET
K962097 · JXG
Cook, Inc.
Neurology · 92d