Fujifilm Irvine Scientific FDA Approvals

0 new drug approvals and 4 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
Fast Warm - NX510(k)Sep 12, 2025Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Sep 12, 2025
cryo-GO Vitrification Device510(k)Sep 26, 2024Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Sep 26, 2024
SSS-NX (Serum Substitute Supplement-NX)510(k)Apr 24, 2024Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Apr 24, 2024
PRIME-XV FreezIS DMSO-Free MD510(k)Nov 9, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Abbreviated)	Nov 9, 2023