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
76-100 of 175
Cleared Mar 19, 2018
Double Flexible Tip Wire Guides
K171912 · DQX
Cardiovascular · 266d
Cleared Mar 09, 2018
Fixed Core Wire Guides
K171764 · DQX
Cardiovascular · 268d
Cleared Mar 09, 2018
Transjugular Liver Access Sets
K171820 · DYB
Cardiovascular · 263d
Cleared Mar 07, 2018
Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
K171810 · KOD
Gastroenterology & Urology · 261d
Cleared Mar 01, 2018
Nathanson Transcystic Bile Duct Stone Exploration Pack
K171915 · LQR
Gastroenterology & Urology · 248d
Cleared Feb 23, 2018
Ultraxx Nephrostomy Balloon Catheter
K171601 · LJE
Gastroenterology & Urology · 267d
Cleared Feb 22, 2018
Silicone Peripherally Inserted Central Venous Catheter Set/Tray
K171994 · LJS
General Hospital · 234d
Cleared Feb 16, 2018
Renal Access Cobra Catheter, Kumpe Access Catheter
K171600 · KOD
Gastroenterology & Urology · 260d
Cleared Feb 15, 2018
Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube...
K171604 · LKF
Obstetrics & Gynecology · 259d
Cleared Feb 01, 2018
Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip...
K171662 · KOD
Gastroenterology & Urology · 241d
Cleared Jan 25, 2018
Royal Flush Catheter
K171264 · DQO
Cardiovascular · 269d
Cleared Jan 10, 2018
Amplatz Support Wire Guide with Apex Curve
K171445 · DQX
Cardiovascular · 239d
Cleared Jan 10, 2018
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans...
K172051 · MQF
Obstetrics & Gynecology · 188d
Cleared Jan 05, 2018
Roadrunner Extra Support Wire Guide
K171948 · DQX
Cardiovascular · 190d
Cleared Dec 21, 2017
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination...
K172321 · MQF
Obstetrics & Gynecology · 142d
Cleared Dec 20, 2017
Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus...
K171275 · DYB
Cardiovascular · 233d
Cleared Dec 20, 2017
Peel-Away Introducer Set
K173685 · DYB
Cardiovascular · 19d
Cleared Dec 15, 2017
Strange Bile Duct Stone Exploration Set
K173687 · LQR
Gastroenterology & Urology · 14d
Cleared Dec 13, 2017
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral...
K172217 · FED
Gastroenterology & Urology · 142d
Cleared Dec 12, 2017
Wittich Nitinol Stone Basket
K170898 · LQR
Gastroenterology & Urology · 260d
Cleared Nov 22, 2017
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
K172278 · GBM
Gastroenterology & Urology · 117d
Cleared Nov 17, 2017
Performer Introducer
K173068 · DYB
Cardiovascular · 49d
Cleared Nov 17, 2017
Gastric Sizing Balloon Catheter
K173355 · KNT
Gastroenterology & Urology · 23d
Cleared Nov 15, 2017
Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and...
K173289 · DQO
Cardiovascular · 30d
Cleared Nov 13, 2017
CXI TriForce Peripheral Crossing Set
K170931 · KRA
Cardiovascular · 229d

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