Fujifilm Corporaton FDA Approvals

0 new drug approvals and 5 device clearances on file. Matched by name to FUJIY.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
FUJIFILM Endoscope Model EI-740D/S510(k)Jan 27, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jan 27, 2023
Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D510(k)Jan 11, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Jan 11, 2023
FUJIFILM Endoscope Model EB-710P510(k)Nov 10, 2022Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Nov 10, 2022
FUJIFILM Video Laparoscope EL-R740M30510(k)Dec 2, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Dec 2, 2021
Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0510(k)Jun 30, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 30, 2021