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."
49–72 of 190
Search insights Median review: 90d Cleared: 100% Top manufacturer: Cook, Inc. Lead specialty: Cardiovascular
Cleared Dec 20, 2006
FLIPPER DETACHABLE EMBOLIZATION COILS
K063619 · KRD
Cook, Inc.
Cardiovascular · 15d
Cleared Nov 14, 2006
ATB ADVANCED PTA DILATATION CATHETER
K063252 · DQY
Cook, Inc.
Cardiovascular · 18d
Cleared Feb 17, 2006
SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
K060174 · FOZ
Cook, Inc.
General Hospital · 25d
Cleared Dec 09, 2005
COOK FORMULA 418 BILIARY STENT SYSTEM
K052539 · FGE
Cook, Inc.
Gastroenterology & Urology · 85d
Cleared Dec 08, 2005
MIRA-FLEX 18 MICROCATHETER
K052841 · KRA
Cook, Inc.
Cardiovascular · 62d
Cleared Nov 23, 2005
MREYE EMBOLIZATION COIL
K052834 · KRD
Cook, Inc.
Cardiovascular · 48d
Cleared Nov 08, 2005
VERTEFIX VERTEBROPLASTY PROCEDURE SET
K042691 · NDN
Cook, Inc.
Orthopedic · 405d
Cleared Aug 25, 2005
ATB ADVANCE PTA DILATATION CATHETER
K052036 · DQY
Cook, Inc.
Cardiovascular · 28d
Cleared Aug 23, 2005
FORMULA 418 BILIARY STENT
K051785 · FGE
Cook, Inc.
Gastroenterology & Urology · 53d
Cleared Jul 21, 2005
TURBO-FLO PICC
K041849 · LJS
Cook, Inc.
General Hospital · 378d
Cleared Jul 12, 2005
ZILVER 635 BILIARY STENT
K051124 · FGE
Cook, Inc.
Gastroenterology & Urology · 70d
Cleared May 05, 2005
GUNTHER TULIP VENA CAVA FILTER SET
K043509 · DTK
Cook, Inc.
Cardiovascular · 136d
Cleared Mar 30, 2005
MODIFICATION TO:ZILVER 518 BILIARY STENT
K050698 · FGE
Cook, Inc.
Gastroenterology & Urology · 13d
Cleared Dec 29, 2004
MODIFICATION TO: ZILVER 635 BILIARY STENT
K043481 · FGE
Cook, Inc.
Gastroenterology & Urology · 14d
Cleared Nov 12, 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611 · DQX
Cook, Inc.
Cardiovascular · 49d
Cleared Oct 01, 2004
ZILVER 518 BILIARY STENT
K042518 · FGE
Cook, Inc.
Gastroenterology & Urology · 15d
Cleared Aug 12, 2004
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
K033843 · FOZ
Cook, Inc.
General Hospital · 246d
Cleared Jul 29, 2004
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
K041044 · JOH
Cook, Inc.
Anesthesiology · 98d
Cleared Apr 02, 2004
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K033875 · DQY
Cook, Inc.
Cardiovascular · 109d
Cleared Mar 16, 2004
ZILVER 635 BILIARY STENT
K040505 · FGE
Cook, Inc.
Gastroenterology & Urology · 18d
Cleared Feb 26, 2004
COOK FIVE LUMEN CENTRAL VENOUS CATHETER
K032274 · FOZ
Cook, Inc.
General Hospital · 218d
Cleared Dec 15, 2003
ZILVER 518 BILIARY STENT
K033348 · FGE
Cook, Inc.
Gastroenterology & Urology · 56d
Cleared Nov 19, 2003
COOK CODA BALLOON CATHETER
K032869 · DQY
Cook, Inc.
Cardiovascular · 65d
Cleared Oct 31, 2003
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
K032426 · DTK
Cook, Inc.
Cardiovascular · 86d