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."
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