Exini Diagnostics AB 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
aPROMISE X510(k)Apr 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 29, 2022
aPROMISE510(k)Jul 27, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 27, 2021