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."
169–190 of 190
Search insights Median review: 90d Cleared: 100% Top manufacturer: Cook, Inc. Lead specialty: Cardiovascular
Cleared Sep 27, 1988
EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER
K882771 · DWF
Cook, Inc.
Cardiovascular · 83d
Cleared Sep 14, 1988
OMEGA NV(TM) BALLOON DILATATION CATHETER
K882052 · LIT
Cook, Inc.
Cardiovascular · 121d
Cleared Aug 19, 1988
COATING FOR WIRE GUIDE
K880722 · DQX
Cook, Inc.
Cardiovascular · 178d
Cleared Jul 28, 1988
SLIP-COAT(TM) CATHETERS
K882796 · DQO
Cook, Inc.
Cardiovascular · 22d
Cleared Jun 17, 1988
MODIFIED COPE SUTURE ANCHOR
K873606 · FGE
Cook, Inc.
Gastroenterology & Urology · 283d
Cleared Aug 12, 1987
DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)
K870215 · LIT
Cook, Inc.
Cardiovascular · 204d
Cleared May 14, 1987
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
K870181 · BTO
Cook, Inc.
Anesthesiology · 119d
Cleared Oct 30, 1986
COOK (R) VEIN GRAFT RING MARKERS
K864101 · KPK
Cook, Inc.
Cardiovascular · 9d
Cleared Mar 14, 1986
GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION
K851243 · LJS
Cook, Inc.
General Hospital · 381d
Cleared Feb 26, 1986
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO
K851241 · DQY
Cook, Inc.
Cardiovascular · 365d
Cleared Nov 19, 1985
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
K851244 · KDQ
Cook, Inc.
General Hospital · 266d
Cleared Sep 11, 1985
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO
K851242 · FGE
Cook, Inc.
Gastroenterology & Urology · 197d
Cleared Aug 12, 1983
AMPLATZ HEPARIN COATED CATHETER
K832178 · DQY
Cook, Inc.
Cardiovascular · 37d
Cleared May 27, 1983
CARDIAC OUTPUT MEASURE SYSTEM
K831185 · DYG
Cook, Inc.
Cardiovascular · 45d
Cleared Jul 28, 1980
BLADE SEPTOSTOMY CATHETER
K801031 · DXF
Cook, Inc.
Cardiovascular · 88d
Cleared Jun 15, 1979
WHOLEY OCCLUSION BALLOON CATHETER
K772011 · FOZ
Cook, Inc.
General Hospital · 598d
Cleared Oct 30, 1978
VARIABLE STIFFNESS WIRE GUIDE
K781393 · DQX
Cook, Inc.
Cardiovascular · 81d
Cleared Jun 20, 1977
NEEDLE, BIOPSY, BOYD, LUNG
K770523
Cook, Inc.
Pathology · 94d
Cleared Jun 01, 1977
UROLOGICAL BIOPSY BRUSH SET
K770913 · FDX
Cook, Inc.
Gastroenterology & Urology · 13d
Cleared Mar 30, 1977
CATHETER, GRUNTZIG, BALLON
K770522 · DYG
Cook, Inc.
Cardiovascular · 12d
Cleared Jan 26, 1977
PROSTATE BIOPSY NEEDLE
K770122 · KNW
Cook, Inc.
Gastroenterology & Urology · 5d
Cleared Dec 06, 1976
RUTNER UNIVERSAL WEDGE CATHETER
K760858 · KOD
Cook, Inc.
Gastroenterology & Urology · 49d