Biofourmis Singapore Pte., Ltd. FDA Approvals

0 new drug approvals and 2 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
Biofourmis Everion+ (G2)510(k)May 9, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 9, 2024
Everion+ System510(k)Feb 23, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 23, 2023