Olea Medical FDA Approvals

0 new drug approvals and 5 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
CT Perfusion V1.0510(k)Jun 9, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 9, 2023
Olea S.I.A. Neurovascular V1.0510(k)Jun 6, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 6, 2023
MR DWI/FLAIR Measurement V1.0510(k)Apr 26, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 26, 2023
MR Diffusion Perfusion Mismatch V1.0510(k)Jan 13, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 13, 2023
breastscape v1.0510(k)Aug 2, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 2, 2021