Cook, Inc. - FDA 510(k) Cleared Devices
190
Total
179
Cleared
0
Denied
190 devices
Cleared
Jul 11, 2003
COOK GASTRIC SIZING BALLOON CATHETER
Gastroenterology & Urology
116d
Cleared
Jun 26, 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
Cardiovascular
17d
Cleared
May 30, 2003
SPECTRUM SILICONE CATHETER
General Hospital
382d
Cleared
Nov 13, 2002
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
Cardiovascular
26d
Cleared
Sep 27, 2002
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
Cardiovascular
56d
Cleared
Aug 14, 2002
7.0 FR. ENDOBRONCHIAL BLOCKER
Anesthesiology
64d
Cleared
Jul 01, 2002
TRIPLE LUMEN CENTRAL VENOUS CATHETER
General Hospital
280d
Cleared
Apr 22, 2002
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
Anesthesiology
152d
Cleared
Feb 21, 2002
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
Anesthesiology
146d
Cleared
Feb 21, 2002
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
Anesthesiology
146d
Cleared
Dec 20, 2001
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
Anesthesiology
23d
Cleared
Nov 16, 2001
FANELLI BILIARY STENT
Gastroenterology & Urology
261d
Cleared
Nov 08, 2001
SPECTRUM VENTRICULAR CATHETER
Neurology
150d
Cleared
Oct 09, 2001
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
Anesthesiology
280d
Cleared
Sep 06, 2001
LIVER TAMPONADE BALLOON
General & Plastic Surgery
203d
Cleared
Aug 13, 2001
COOK ZILVER BILIARY STENT
Gastroenterology & Urology
200d
Cleared
Mar 22, 2001
LDOB OCCLUSION BALLOON CATHETER
Cardiovascular
238d
Cleared
Mar 16, 2001
COOK PRESSURE MONITORING CATHETER
Cardiovascular
234d
Cleared
Jan 25, 2001
INTRODEUCE DOUBLE LUMEN INTRODUCER
Cardiovascular
210d
Cleared
Jan 24, 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
General Hospital
20d
Cleared
Nov 28, 2000
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
Anesthesiology
124d
Cleared
Nov 24, 2000
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
Neurology
270d
Cleared
Oct 18, 2000
GUNTHER TULIP VENA CAVA MREYE FILTER SET
Cardiovascular
216d
Cleared
Jul 20, 2000
PTA BALLOON CATHETER
Cardiovascular
107d
Cleared
Jan 11, 2000
FLIPPER DETACHABLE EMBOLIZATION COIL
Cardiovascular
90d
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