Combinostics OY 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
cNeuro cDAT510(k)Jul 1, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 1, 2024
cNeuro cPET510(k)Sep 14, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 14, 2023