iSchemaview 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
Rapid Vessel Occlusion (Rapid VO)510(k)Jul 13, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 13, 2026
Rapid CTA 360510(k)Jul 16, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 16, 2025