Faceheart Corp. 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
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)510(k)Apr 9, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Apr 9, 2025
FaceHeart Vitals Software Development Kit (FH vitals SDK)510(k)Sep 1, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 1, 2023