Medical Device Manufacturer · US , Bloomington , IN

Cook Incorporated - FDA 510(k) Cleared Devices

175 submissions · 153 cleared · Since 2006
175
Total
153
Cleared
1
Denied
175 devices
101-125 of 175
Cleared Nov 07, 2017
NCompass Nitinol Stone Extractors
K173009 · LQR
Gastroenterology & Urology · 41d
Cleared Oct 26, 2017
Rhapsody H-30 Holmium Laser System
K172325 · GEX
General & Plastic Surgery · 86d
Cleared Oct 19, 2017
Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set,...
K172527 · LJE
Gastroenterology & Urology · 59d
Cleared Oct 18, 2017
Liberator Beacon Tip Locking Stylet
K170298 · DRB
Cardiovascular · 260d
Cleared Sep 28, 2017
Peel-Away Introducer Set
K170020 · DYB
Cardiovascular · 268d
Cleared Sep 14, 2017
Entuit Start Initial Placement Gastrostomy Set
K170323 · KGC
Gastroenterology & Urology · 225d
Cleared Aug 28, 2017
Salle Intraoperative Pyeloplasty Stent Set
K170010 · FAD
Gastroenterology & Urology · 237d
Cleared Aug 24, 2017
Liver Access and Biopsy Sets
K171853 · DYB
Cardiovascular · 64d
Cleared Aug 21, 2017
Approach CTO Microwire Guide
K171897 · DQX
Cardiovascular · 56d
Cleared Aug 11, 2017
Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway...
K162729 · BSR
Anesthesiology · 316d
Cleared Jul 31, 2017
Performer Introducer
K171999 · DYB
Cardiovascular · 28d
Cleared Jul 28, 2017
Williams Cystoscopic Injection Needle
K171602 · FBK
Gastroenterology & Urology · 57d
Cleared Jul 27, 2017
Bunegin-Albin Air Aspiration Set
K163031 · DXE
Cardiovascular · 269d
Cleared Jul 14, 2017
Soules Intrauterine Insemination Catheter
K163318 · MQF
Obstetrics & Gynecology · 233d
Cleared Jul 11, 2017
Needle's Eye Snare Retrieval Set - 54cm
K163353 · DXE
Cardiovascular · 223d
Cleared Jun 07, 2017
Kwart Retro-Inject Ureteral Stent
K162109 · FAD
Gastroenterology & Urology · 313d
Cleared May 26, 2017
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing...
K162448 · DQO
Cardiovascular · 267d
Cleared May 24, 2017
Cook Holmium Laser Fiber
K163197 · GEX
General & Plastic Surgery · 190d
Cleared May 24, 2017
Tao Brush I.U.M.C. Endometrial Sampler
K170603 · HFE
Obstetrics & Gynecology · 84d
Cleared May 18, 2017
Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube
K160509 · KNT
Gastroenterology & Urology · 449d
Cleared May 18, 2017
Barone Jejunostomy Catheter Set
K160567 · KNT
Gastroenterology & Urology · 444d
Cleared Apr 28, 2017
van Andel Dilatation Catheter
K170616 · DRE
Cardiovascular · 58d
Cleared Apr 24, 2017
C-Flex Ureteral Stent Set
K162104 · FAD
Gastroenterology & Urology · 269d
Cleared Mar 31, 2017
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation...
K170622 · OQY
Obstetrics & Gynecology · 30d
Cleared Feb 28, 2017
Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
K170008 · KNW
Gastroenterology & Urology · 56d

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