Smartcardia SA 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
SmartCardia 7L Platform (MCT)510(k)Oct 31, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 31, 2024
SmartCardia 7L Platform510(k)Aug 30, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 30, 2023