Cook Incorporated - FDA 510(k) Cleared Devices
175
Total
153
Cleared
1
Denied
175 devices
Cleared
Mar 27, 2019
Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
Gastroenterology & Urology
268d
Cleared
Mar 22, 2019
Polyethylene Catheter
Cardiovascular
266d
Cleared
Feb 15, 2019
Lunderquist® Fixed Core Wire Guide
Cardiovascular
269d
Cleared
Jan 18, 2019
Cook Cystostomy Catheter Set
Gastroenterology & Urology
267d
Cleared
Jan 11, 2019
Roadrunner Extra Support Wire Guide
Cardiovascular
28d
Cleared
Dec 26, 2018
One-Step Suprapubic Introducer
Gastroenterology & Urology
90d
Cleared
Dec 20, 2018
Reuter Tip Deflecting Wire Guide
Cardiovascular
265d
Cleared
Dec 20, 2018
Dilator Sets
Cardiovascular
49d
Cleared
Dec 19, 2018
Arterial Pressure Monitoring Set/Tray
Cardiovascular
261d
Not Cleared
Dec 12, 2018
Retrograde Intubation Set
Anesthesiology
443d
Cleared
Nov 30, 2018
Arterial Pressure Monitoring Set/Tray
Cardiovascular
248d
Cleared
Nov 23, 2018
Greene Renal Transplant Stent Set
Gastroenterology & Urology
267d
Cleared
Nov 06, 2018
Günther Tulip® Vena Cava Filter Retrieval Set
Cardiovascular
127d
Cleared
Oct 30, 2018
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
Gastroenterology & Urology
90d
Cleared
Oct 26, 2018
Polyethylene Catheter
Cardiovascular
267d
Cleared
Oct 26, 2018
Cook Silicone Balloon HSG Catheter
Obstetrics & Gynecology
267d
Cleared
Oct 26, 2018
Margolin HSG Cannula, Goldstein Sonohysterography Catheter
Obstetrics & Gynecology
266d
Cleared
Oct 24, 2018
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™...
Obstetrics & Gynecology
264d
Cleared
Oct 05, 2018
Royal Flush Plus High-Flow Catheter
Cardiovascular
270d
Cleared
Sep 28, 2018
Seidmon Antegrade AQ Stent Set
Gastroenterology & Urology
246d
Cleared
Sep 21, 2018
Malecot Nephrostomy Catheter/Stent Set
Gastroenterology & Urology
261d
Cleared
Sep 14, 2018
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access...
Gastroenterology & Urology
234d
Cleared
Sep 13, 2018
Sof-Flex Ureteral Stent Set
Gastroenterology & Urology
248d
Cleared
Aug 23, 2018
Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
Gastroenterology & Urology
267d
Cleared
Aug 17, 2018
Ultraxx Nephrostomy Balloon Catheter Set
Gastroenterology & Urology
50d
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