Cook, Inc. - FDA 510(k) Cleared Devices
190
Total
179
Cleared
0
Denied
190 devices
Cleared
Aug 25, 2010
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
Anesthesiology
65d
Cleared
Aug 06, 2010
OCCLUSION BALLOON CATHETER MODEL OBC
Cardiovascular
31d
Cleared
Apr 23, 2010
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE,...
Anesthesiology
81d
Cleared
Feb 26, 2010
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
Anesthesiology
136d
Cleared
Jan 08, 2010
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL:...
Anesthesiology
63d
Cleared
Dec 08, 2009
CROSSCATH SUPPORT CATHTER
Cardiovascular
69d
Cleared
Aug 07, 2009
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
Cardiovascular
89d
Cleared
Jun 12, 2009
ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER
Cardiovascular
17d
Cleared
Apr 27, 2009
ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER
Cardiovascular
32d
Cleared
Apr 02, 2009
COOK MREYE EMBOLIZATION COILS
Cardiovascular
24d
Cleared
Feb 20, 2009
CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
Gastroenterology & Urology
30d
Cleared
Aug 08, 2008
MIRAFLEX HIGH FLOW MICROCATHETER
Cardiovascular
144d
Cleared
Aug 01, 2008
MODIFICATION TO ZILVER 635 BILIARY STENT
Gastroenterology & Urology
207d
Cleared
Jul 30, 2008
COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
General Hospital
103d
Cleared
Jul 14, 2008
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
General Hospital
27d
Cleared
Mar 04, 2008
FLEXOR EVAC ASPIRATION CATHETER
Cardiovascular
69d
Cleared
Dec 28, 2007
ADVANCE 18LP PTA DILATATION CATHETER
Cardiovascular
25d
Cleared
Dec 13, 2007
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
General Hospital
87d
Cleared
Nov 09, 2007
CXI SUPPORT CATHETER
Cardiovascular
44d
Cleared
Nov 08, 2007
GUNTHER TULIP VENA CAVA FILTER
Cardiovascular
87d
Cleared
Oct 03, 2007
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
Anesthesiology
61d
Cleared
Jul 12, 2007
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
Neurology
27d
Cleared
Apr 27, 2007
COOK MICROWIRE WIRE GUIDE
Cardiovascular
74d
Cleared
Dec 20, 2006
FLIPPER DETACHABLE EMBOLIZATION COILS
Cardiovascular
15d
Cleared
Nov 14, 2006
ATB ADVANCED PTA DILATATION CATHETER
Cardiovascular
18d
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