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."
73–96 of 190
Search insights Median review: 90d Cleared: 100% Top manufacturer: Cook, Inc. Lead specialty: Cardiovascular
Cleared Oct 22, 2003
PTA BALLOON CATHETER
K032931 · DQY
Cook, Inc.
Cardiovascular · 30d
Cleared Oct 16, 2003
ENK FIBEROPTIC ATOMIZER SET
K031966 · EOQ
Cook, Inc.
Ear, Nose, Throat · 112d
Cleared Jul 18, 2003
MODIFICATION TO COOK ZILVER BILIARY STENT
K031821 · FGE
Cook, Inc.
Gastroenterology & Urology · 35d
Cleared Jul 11, 2003
COOK GASTRIC SIZING BALLOON CATHETER
K030841 · KNT
Cook, Inc.
Gastroenterology & Urology · 116d
Cleared Jun 26, 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K031766 · DQY
Cook, Inc.
Cardiovascular · 17d
Cleared May 30, 2003
SPECTRUM SILICONE CATHETER
K021557 · FOZ
Cook, Inc.
General Hospital · 382d
Cleared Nov 13, 2002
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K023504 · LIT
Cook, Inc.
Cardiovascular · 26d
Cleared Sep 27, 2002
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K022552 · DQY
Cook, Inc.
Cardiovascular · 56d
Cleared Aug 14, 2002
7.0 FR. ENDOBRONCHIAL BLOCKER
K021920 · CBI
Cook, Inc.
Anesthesiology · 64d
Cleared Jul 01, 2002
TRIPLE LUMEN CENTRAL VENOUS CATHETER
K013182 · FOZ
Cook, Inc.
General Hospital · 280d
Cleared Apr 22, 2002
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
K013865 · CBI
Cook, Inc.
Anesthesiology · 152d
Cleared Feb 21, 2002
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
K013252 · BWC
Cook, Inc.
Anesthesiology · 146d
Cleared Feb 21, 2002
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
K013241 · BWC
Cook, Inc.
Anesthesiology · 146d
Cleared Dec 20, 2001
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
K013916 · BWC
Cook, Inc.
Anesthesiology · 23d
Cleared Nov 16, 2001
FANELLI BILIARY STENT
K010601 · FGE
Cook, Inc.
Gastroenterology & Urology · 261d
Cleared Nov 08, 2001
SPECTRUM VENTRICULAR CATHETER
K011812 · NHC
Cook, Inc.
Neurology · 150d
Cleared Oct 09, 2001
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
K010016 · BWC
Cook, Inc.
Anesthesiology · 280d
Cleared Sep 06, 2001
LIVER TAMPONADE BALLOON
K010450 · NGU
Cook, Inc.
General & Plastic Surgery · 203d
Cleared Aug 13, 2001
COOK ZILVER BILIARY STENT
K010242 · FGE
Cook, Inc.
Gastroenterology & Urology · 200d
Cleared Mar 22, 2001
LDOB OCCLUSION BALLOON CATHETER
K002286 · MJN
Cook, Inc.
Cardiovascular · 238d
Cleared Mar 16, 2001
COOK PRESSURE MONITORING CATHETER
K002254 · DQO
Cook, Inc.
Cardiovascular · 234d
Cleared Jan 25, 2001
INTRODEUCE DOUBLE LUMEN INTRODUCER
K001985 · DYB
Cook, Inc.
Cardiovascular · 210d
Cleared Jan 24, 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
K010034 · FOZ
Cook, Inc.
General Hospital · 20d
Cleared Nov 28, 2000
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
K002288 · CBI
Cook, Inc.
Anesthesiology · 124d