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."
1–24 of 190
Search insights Median review: 90d Cleared: 100% Top manufacturer: Cook, Inc. Lead specialty: Cardiovascular
Cleared Jan 09, 2015
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
K133130 · DQO
Cook, Inc.
Cardiovascular · 466d
Cleared Dec 15, 2014
ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
K140593 · GCJ
Cook, Inc.
General & Plastic Surgery · 283d
Cleared Oct 09, 2014
FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
K132592 · DYB
Cook, Inc.
Cardiovascular · 416d
Cleared Apr 18, 2014
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO...
K133597 · JOH
Cook, Inc.
Anesthesiology · 147d
Cleared Feb 20, 2014
CANTATA(R) 2.9 MICROCATHETER
K131772 · KRA
Cook, Inc.
Cardiovascular · 248d
Cleared Jan 29, 2014
ADVANCE CS CORONARY SINUS INFUSION CATHETER
K131204 · DQY
Cook, Inc.
Cardiovascular · 275d
Cleared Dec 23, 2013
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
K133634 · LJS
Cook, Inc.
General Hospital · 27d
Cleared Oct 25, 2013
ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K132020 · LIT
Cook, Inc.
Cardiovascular · 116d
Cleared Oct 07, 2013
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE...
K131201 · FGE
Cook, Inc.
Gastroenterology & Urology · 161d
Cleared Sep 27, 2013
COOK CERVICAL RIPENING BALLOON
K131206 · PFJ
Cook, Inc.
Obstetrics & Gynecology · 151d
Cleared Aug 16, 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
K132334 · LJS
Cook, Inc.
General Hospital · 21d
Cleared Jul 29, 2013
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM...
K122091 · MPB
Cook, Inc.
Gastroenterology & Urology · 378d
Cleared Jul 17, 2013
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
K130766 · DQX
Cook, Inc.
Cardiovascular · 119d
Cleared Jun 28, 2013
CODA BALLOON CATHETER
K122917 · DQY
Cook, Inc.
Cardiovascular · 276d
Cleared May 31, 2013
ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K130293 · LIT
Cook, Inc.
Cardiovascular · 114d
Cleared May 22, 2013
H-30 HOLMIUM LASER SYSTEM
K130444 · GEX
Cook, Inc.
General & Plastic Surgery · 90d
Cleared Mar 19, 2013
ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3
K122940 · DQY
Cook, Inc.
Cardiovascular · 176d
Cleared Feb 28, 2013
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
K123707 · DQX
Cook, Inc.
Cardiovascular · 87d
Cleared Dec 14, 2012
SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT...
K122937 · DQO
Cook, Inc.
Cardiovascular · 81d
Cleared Oct 11, 2012
CXI SUPPORT CATHETER
K122796 · KRA
Cook, Inc.
Cardiovascular · 29d
Cleared Dec 09, 2011
ATB ADVANCE PTA DILATATION CATHETER
K113300 · LIT
Cook, Inc.
Cardiovascular · 30d
Cleared Nov 02, 2011
FOURSNARE VASCULAR RETRIEVAL SNARE
K112185 · MMX
Cook, Inc.
Cardiovascular · 96d
Cleared Jun 14, 2011
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K111244 · LJS
Cook, Inc.
General Hospital · 42d
Cleared Feb 02, 2011
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
K110009 · DQX
Cook, Inc.
Cardiovascular · 30d