Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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