Filmecc Co., Ltd. FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

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
CROSSLEAD Standard 035 and CROSSLEAD Stiff 035510(k)Sep 3, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 3, 2026
Vassallo GT 018 Hybrid510(k)Mar 9, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 9, 2023
VASSALLO GT EXT510(k)Oct 26, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 26, 2022
VASSALLO GT 018 Floppy510(k)Jun 30, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 30, 2022
VASSALLO GT Hybrid510(k)May 4, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 4, 2021
VASSALLO GT510(k)Apr 21, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 21, 2021