Medical Device Manufacturer · US , Stamford , CT

Fujifilm Medical System U.S.A., Inc. - FDA 510(k) Cleared Devices

71 submissions · 71 cleared · Since 1988

Recent clearances: Processor VP-7000, Light Source BL-7000, Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1, Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)

71

Total

71

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fujifilm Medical System U.S.A., Inc. Gastroenterology & Urology ✕

6 devices

1-6 of 6

Cleared Apr 25, 2017

Processor VP-7000, Light Source BL-7000

Gastroenterology & Urology · 119d

Cleared Mar 03, 2016

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1

Gastroenterology & Urology · 119d

Cleared Feb 18, 2016

Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)

Gastroenterology & Urology · 262d

Cleared Oct 01, 2015

EPX-4440HD and EPX-4400HD with FICE

Gastroenterology & Urology · 244d

Cleared May 14, 2015

EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes

Gastroenterology & Urology · 240d

Cleared Sep 09, 2014

FUJIFILM ENDOSCOPIC CO2 REGULATOR

Gastroenterology & Urology · 257d