Cook, Inc. - FDA 510(k) Cleared Devices
190
Total
179
Cleared
0
Denied
190 devices
Cleared
Feb 17, 2006
SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
General Hospital
25d
Cleared
Dec 09, 2005
COOK FORMULA 418 BILIARY STENT SYSTEM
Gastroenterology & Urology
85d
Cleared
Dec 08, 2005
MIRA-FLEX 18 MICROCATHETER
Cardiovascular
62d
Cleared
Nov 23, 2005
MREYE EMBOLIZATION COIL
Cardiovascular
48d
Cleared
Nov 08, 2005
VERTEFIX VERTEBROPLASTY PROCEDURE SET
Orthopedic
405d
Cleared
Aug 25, 2005
ATB ADVANCE PTA DILATATION CATHETER
Cardiovascular
28d
Cleared
Aug 23, 2005
FORMULA 418 BILIARY STENT
Gastroenterology & Urology
53d
Cleared
Jul 21, 2005
TURBO-FLO PICC
General Hospital
378d
Cleared
Jul 12, 2005
ZILVER 635 BILIARY STENT
Gastroenterology & Urology
70d
Cleared
May 05, 2005
GUNTHER TULIP VENA CAVA FILTER SET
Cardiovascular
136d
Cleared
Mar 30, 2005
MODIFICATION TO:ZILVER 518 BILIARY STENT
Gastroenterology & Urology
13d
Cleared
Dec 29, 2004
MODIFICATION TO: ZILVER 635 BILIARY STENT
Gastroenterology & Urology
14d
Cleared
Nov 12, 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
Cardiovascular
49d
Cleared
Oct 01, 2004
ZILVER 518 BILIARY STENT
Gastroenterology & Urology
15d
Cleared
Aug 12, 2004
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
General Hospital
246d
Cleared
Jul 29, 2004
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
Anesthesiology
98d
Cleared
Apr 02, 2004
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
Cardiovascular
109d
Cleared
Mar 16, 2004
ZILVER 635 BILIARY STENT
Gastroenterology & Urology
18d
Cleared
Feb 26, 2004
COOK FIVE LUMEN CENTRAL VENOUS CATHETER
General Hospital
218d
Cleared
Dec 15, 2003
ZILVER 518 BILIARY STENT
Gastroenterology & Urology
56d
Cleared
Nov 19, 2003
COOK CODA BALLOON CATHETER
Cardiovascular
65d
Cleared
Oct 31, 2003
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
Cardiovascular
86d
Cleared
Oct 22, 2003
PTA BALLOON CATHETER
Cardiovascular
30d
Cleared
Oct 16, 2003
ENK FIBEROPTIC ATOMIZER SET
Ear, Nose, Throat
112d
Cleared
Jul 18, 2003
MODIFICATION TO COOK ZILVER BILIARY STENT
Gastroenterology & Urology
35d
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