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."
25–48 of 190
Search insights Median review: 90d Cleared: 100% Top manufacturer: Cook, Inc. Lead specialty: Cardiovascular
Cleared Dec 30, 2010
CANTATA MICROCATHETER
K101450 · KRA
Cook, Inc.
Cardiovascular · 220d
Cleared Aug 25, 2010
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
K101728 · BSP
Cook, Inc.
Anesthesiology · 65d
Cleared Aug 06, 2010
OCCLUSION BALLOON CATHETER MODEL OBC
K101877 · DQY
Cook, Inc.
Cardiovascular · 31d
Cleared Apr 23, 2010
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE,...
K100283 · BTO
Cook, Inc.
Anesthesiology · 81d
Cleared Feb 26, 2010
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
K093209 · BSP
Cook, Inc.
Anesthesiology · 136d
Cleared Jan 08, 2010
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL:...
K093469 · JOH
Cook, Inc.
Anesthesiology · 63d
Cleared Dec 08, 2009
CROSSCATH SUPPORT CATHTER
K093052 · KRA
Cook, Inc.
Cardiovascular · 69d
Cleared Aug 07, 2009
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
K091385 · DQX
Cook, Inc.
Cardiovascular · 89d
Cleared Jun 12, 2009
ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K091527 · DQY
Cook, Inc.
Cardiovascular · 17d
Cleared Apr 27, 2009
ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER
K090822 · DQY
Cook, Inc.
Cardiovascular · 32d
Cleared Apr 02, 2009
COOK MREYE EMBOLIZATION COILS
K090624 · KRD
Cook, Inc.
Cardiovascular · 24d
Cleared Feb 20, 2009
CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
K090133 · FGE
Cook, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 08, 2008
MIRAFLEX HIGH FLOW MICROCATHETER
K080737 · KRA
Cook, Inc.
Cardiovascular · 144d
Cleared Aug 01, 2008
MODIFICATION TO ZILVER 635 BILIARY STENT
K080037 · FGE
Cook, Inc.
Gastroenterology & Urology · 207d
Cleared Jul 30, 2008
COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
K081113 · FOZ
Cook, Inc.
General Hospital · 103d
Cleared Jul 14, 2008
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
K081690 · FOZ
Cook, Inc.
General Hospital · 27d
Cleared Mar 04, 2008
FLEXOR EVAC ASPIRATION CATHETER
K073627 · QEZ
Cook, Inc.
Cardiovascular · 69d
Cleared Dec 28, 2007
ADVANCE 18LP PTA DILATATION CATHETER
K073378 · DQY
Cook, Inc.
Cardiovascular · 25d
Cleared Dec 13, 2007
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K072625 · LJS
Cook, Inc.
General Hospital · 87d
Cleared Nov 09, 2007
CXI SUPPORT CATHETER
K072724 · KRA
Cook, Inc.
Cardiovascular · 44d
Cleared Nov 08, 2007
GUNTHER TULIP VENA CAVA FILTER
K072240 · DTK
Cook, Inc.
Cardiovascular · 87d
Cleared Oct 03, 2007
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
K072148 · JOH
Cook, Inc.
Anesthesiology · 61d
Cleared Jul 12, 2007
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
K071640 · NHC
Cook, Inc.
Neurology · 27d
Cleared Apr 27, 2007
COOK MICROWIRE WIRE GUIDE
K070410 · DQX
Cook, Inc.
Cardiovascular · 74d