Caristo Diagnostics , 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
CaRi-Heart510(k)Jul 28, 2026Cardiovascular	Cardiovascular	510(k)Unknown (Direct)	Jul 28, 2026
CaRi-Plaque510(k)Feb 20, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 20, 2025