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."
145–168 of 190
Search insights Median review: 90d Cleared: 100% Top manufacturer: Cook, Inc. Lead specialty: Cardiovascular
Cleared Jul 02, 1992
MCLEAN-STOCK PERCUTANEOUS T-TUBE SET
K921654 · FGE
Cook, Inc.
Gastroenterology & Urology · 86d
Cleared May 15, 1992
GIANTURCO-ROSCH BILIARY Z STENT
K921191 · FGE
Cook, Inc.
Gastroenterology & Urology · 78d
Cleared May 01, 1992
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
K914856 · DQY
Cook, Inc.
Cardiovascular · 185d
Cleared Mar 04, 1992
INTRAOSSEOUS ACCESS NEEDLE
K915409 · FMI
Cook, Inc.
General Hospital · 93d
Cleared Mar 04, 1992
DISPOSABLE INTROSSEOUS INFUSION NEEDLES
K913258 · FMI
Cook, Inc.
General Hospital · 225d
Cleared Dec 18, 1991
GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT
K891411 · JCT
Cook, Inc.
General & Plastic Surgery · 1009d
Cleared Dec 09, 1991
ESOPHAGEAL Z-STENT
K914029 · ESW
Cook, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 22, 1991
ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER
K900677 · LIT
Cook, Inc.
Cardiovascular · 375d
Cleared Feb 01, 1991
VASCULAR RETRIEVAL FORCEPS
K902999 · DQY
Cook, Inc.
Cardiovascular · 207d
Cleared Nov 13, 1990
HILAL EMBOLIZATION MICROCOIL(TM)
K901337 · HCG
Cook, Inc.
Neurology · 236d
Cleared Oct 12, 1990
HYSTEROSCOPY SHEATH SET
K903146 · HIH
Cook, Inc.
Obstetrics & Gynecology · 86d
Cleared Oct 12, 1990
LAPAROSCOPIC ACCESS SHEATH SET
K903124 · HET
Cook, Inc.
Obstetrics & Gynecology · 88d
Cleared Oct 10, 1990
COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION
K903858 · FGE
Cook, Inc.
Gastroenterology & Urology · 51d
Cleared Sep 27, 1990
ROADRUNNER WIRE GUIDE
K901899 · DQX
Cook, Inc.
Cardiovascular · 153d
Cleared Sep 26, 1990
DEFLECTING WIRE GRASPER
K903707 · HCZ
Cook, Inc.
Obstetrics & Gynecology · 42d
Cleared Sep 12, 1990
COPE NITINOL STONE BASKET
K902945 · LQR
Cook, Inc.
Gastroenterology & Urology · 69d
Cleared Sep 12, 1990
WITTICH NITINOL STONE BASKET
K902944 · LQR
Cook, Inc.
Gastroenterology & Urology · 69d
Cleared Sep 04, 1990
COOK CORONARY GUIDING CATHETER
K902905 · DQY
Cook, Inc.
Cardiovascular · 64d
Cleared May 31, 1990
COOK STEREOTAXIC GUIDE
K900200 · HAW
Cook, Inc.
Neurology · 135d
Cleared May 02, 1990
MAGNET RETRIEVAL CATHETER
K900852 · KNT
Cook, Inc.
Gastroenterology & Urology · 69d
Cleared Feb 26, 1990
DUAL GUIDE INTRODUCER CATHETER
K895044 · DYB
Cook, Inc.
Cardiovascular · 201d
Cleared Apr 21, 1989
COOK-GIANTURCO BILIARY Z STENT
K882610 · FGE
Cook, Inc.
Gastroenterology & Urology · 301d
Cleared Dec 08, 1988
COOK HYSTEROCATH(TM)
K884291 · KNA
Cook, Inc.
Obstetrics & Gynecology · 57d
Cleared Dec 05, 1988
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
K883723 · DWZ
Cook, Inc.
Cardiovascular · 96d