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."
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