Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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