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."
73–96 of 190
Search insights Median review: 90d Cleared: 100% Top manufacturer: Cook, Inc. Lead specialty: Cardiovascular
Cleared Oct 22, 2003
PTA BALLOON CATHETER
K032931 · DQY
Cook, Inc.
Cardiovascular · 30d
Cleared Oct 16, 2003
ENK FIBEROPTIC ATOMIZER SET
K031966 · EOQ
Cook, Inc.
Ear, Nose, Throat · 112d
Cleared Jul 18, 2003
MODIFICATION TO COOK ZILVER BILIARY STENT
K031821 · FGE
Cook, Inc.
Gastroenterology & Urology · 35d
Cleared Jul 11, 2003
COOK GASTRIC SIZING BALLOON CATHETER
K030841 · KNT
Cook, Inc.
Gastroenterology & Urology · 116d
Cleared Jun 26, 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K031766 · DQY
Cook, Inc.
Cardiovascular · 17d
Cleared May 30, 2003
SPECTRUM SILICONE CATHETER
K021557 · FOZ
Cook, Inc.
General Hospital · 382d
Cleared Nov 13, 2002
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K023504 · LIT
Cook, Inc.
Cardiovascular · 26d
Cleared Sep 27, 2002
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K022552 · DQY
Cook, Inc.
Cardiovascular · 56d
Cleared Aug 14, 2002
7.0 FR. ENDOBRONCHIAL BLOCKER
K021920 · CBI
Cook, Inc.
Anesthesiology · 64d
Cleared Jul 01, 2002
TRIPLE LUMEN CENTRAL VENOUS CATHETER
K013182 · FOZ
Cook, Inc.
General Hospital · 280d
Cleared Apr 22, 2002
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
K013865 · CBI
Cook, Inc.
Anesthesiology · 152d
Cleared Feb 21, 2002
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
K013252 · BWC
Cook, Inc.
Anesthesiology · 146d
Cleared Feb 21, 2002
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
K013241 · BWC
Cook, Inc.
Anesthesiology · 146d
Cleared Dec 20, 2001
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
K013916 · BWC
Cook, Inc.
Anesthesiology · 23d
Cleared Nov 16, 2001
FANELLI BILIARY STENT
K010601 · FGE
Cook, Inc.
Gastroenterology & Urology · 261d
Cleared Nov 08, 2001
SPECTRUM VENTRICULAR CATHETER
K011812 · NHC
Cook, Inc.
Neurology · 150d
Cleared Oct 09, 2001
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
K010016 · BWC
Cook, Inc.
Anesthesiology · 280d
Cleared Sep 06, 2001
LIVER TAMPONADE BALLOON
K010450 · NGU
Cook, Inc.
General & Plastic Surgery · 203d
Cleared Aug 13, 2001
COOK ZILVER BILIARY STENT
K010242 · FGE
Cook, Inc.
Gastroenterology & Urology · 200d
Cleared Mar 22, 2001
LDOB OCCLUSION BALLOON CATHETER
K002286 · MJN
Cook, Inc.
Cardiovascular · 238d
Cleared Mar 16, 2001
COOK PRESSURE MONITORING CATHETER
K002254 · DQO
Cook, Inc.
Cardiovascular · 234d
Cleared Jan 25, 2001
INTRODEUCE DOUBLE LUMEN INTRODUCER
K001985 · DYB
Cook, Inc.
Cardiovascular · 210d
Cleared Jan 24, 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
K010034 · FOZ
Cook, Inc.
General Hospital · 20d
Cleared Nov 28, 2000
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
K002288 · CBI
Cook, Inc.
Anesthesiology · 124d