CraniUS, LLC 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
CraniUS Plate510(k)Sep 11, 2026Neurology	Neurology	510(k)Substantially Equivalent (Special)	Sep 11, 2026
CraniUS Plate510(k)Jul 29, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 29, 2026