Olea Medical S.A.S. FDA Approvals

0 new drug approvals and 3 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
Neurovascular Insight V1.0510(k)Aug 25, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 25, 2025
Neuro Insight V1.0510(k)Jul 23, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 23, 2025
Functional MR V1.0510(k)Jul 6, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 6, 2022