Medical Device Manufacturer · IL , Ra?Anana

Urogen Pharma, Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2018

5

Total

5

Cleared

0

Denied

FDA 510(k) cleared devices by Urogen Pharma, Ltd. Gastroenterology & Urology ✕

5 devices

1-5 of 5

Cleared Nov 19, 2021

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr

Gastroenterology & Urology · 226d

Cleared Dec 09, 2020

Cystoject Syringe Lever

Gastroenterology & Urology · 27d

Cleared Dec 02, 2019

Uroject12 Syringe Lever

Gastroenterology & Urology · 231d

Cleared Oct 30, 2018

UroGen Ureteral Catheter

Gastroenterology & Urology · 264d

Cleared Oct 17, 2018

Uroject12 Syringe Lever

Gastroenterology & Urology · 251d