Stephanix 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
D²RS and D²RS 9090510(k)Jun 7, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jun 7, 2022
D²RS and D²RS 9090510(k)Dec 23, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 23, 2021
MOVIX DReamy510(k)Nov 3, 2021Radiology	Radiology	510(k)Substantially Equivalent (Abbreviated)	Nov 3, 2021