Cook Incorporated - FDA 510(k) Cleared Devices
175
Total
153
Cleared
1
Denied
175 devices
Cleared
Feb 17, 2017
Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal...
Anesthesiology
386d
Cleared
Feb 13, 2017
Advance 14LP Low Profile PTA Balloon Dilatation Catheter
Cardiovascular
21d
Cleared
Jan 27, 2017
Universa Firm Ureteral Stents and Stent Sets
Gastroenterology & Urology
270d
Cleared
Jan 06, 2017
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
Gastroenterology & Urology
219d
Cleared
Nov 22, 2016
CXI Support Catheter
Cardiovascular
236d
Cleared
Oct 27, 2016
Torcon NB Advantage Catheters
Cardiovascular
118d
Cleared
Oct 07, 2016
Turbo-Flo PICC Sets
General Hospital
128d
Cleared
Oct 06, 2016
uVue HSG/SHG Catheter
Obstetrics & Gynecology
251d
Cleared
Sep 28, 2016
Aprima Smartesis Centesis Pump
General & Plastic Surgery
170d
Cleared
Sep 22, 2016
Emergency Transtracheal Airway Catheter
Anesthesiology
267d
Cleared
Sep 02, 2016
Indy OTW Vascular Retriever
Cardiovascular
185d
Cleared
Aug 03, 2016
Hilal Embolization MicroCoils
Cardiovascular
187d
Cleared
Aug 02, 2016
5.0 Fr Arndt Endobronchial Blocker Set
Anesthesiology
158d
Cleared
Jul 29, 2016
CrossCath Support Catheter
Cardiovascular
29d
Cleared
Jul 26, 2016
Cook Intraosseous Infusion Needles
General Hospital
117d
Cleared
Jul 22, 2016
Gianturco-Roehm Bird’s Nest Vena Cava Filter
Cardiovascular
84d
Cleared
Jun 24, 2016
Ultrathane Endoureterotomy Stent Set
Gastroenterology & Urology
85d
Cleared
May 19, 2016
Nester Embolization Coils, Tornado Embolization Coils
Cardiovascular
140d
Cleared
Apr 08, 2016
VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic...
Neurology
70d
Cleared
Mar 07, 2016
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
Cardiovascular
103d
Cleared
Jan 11, 2016
Universa Soft Ureteral Stents and Stent Sets
Gastroenterology & Urology
266d
Cleared
Jan 08, 2016
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction...
Obstetrics & Gynecology
267d
Cleared
Dec 18, 2015
Flexipet Denuding Pipette, Flexipet Manipulation Pipette
Obstetrics & Gynecology
270d
Cleared
Dec 18, 2015
MReye Embolization Coils
Cardiovascular
256d
Cleared
Dec 18, 2015
MReye Flipper Detachable Embolization Coil and Delivery System
Cardiovascular
252d
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