Medical Device Manufacturer · US , Stamford , CT

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

71 submissions · 71 cleared · Since 1988
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
K163675 · FET
Gastroenterology & Urology · 119d
Cleared Mar 03, 2016
Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
K153206 · FDS
Gastroenterology & Urology · 119d
Cleared Feb 18, 2016
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
K151474 · KGE
Gastroenterology & Urology · 262d
Cleared Oct 01, 2015
EPX-4440HD and EPX-4400HD with FICE
K150221 · FET
Gastroenterology & Urology · 244d
Cleared May 14, 2015
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
K142629 · FDS
Gastroenterology & Urology · 240d
Cleared Sep 09, 2014
FUJIFILM ENDOSCOPIC CO2 REGULATOR
K133976 · FCX
Gastroenterology & Urology · 257d
Filters
Filter by Specialty
All71 Radiology 64 Gastroenterology & Urology 6 Ear, Nose, Throat 1