Bien-Air Surgery SA 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
ORiGO System510(k)Nov 2, 2022Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Nov 2, 2022
ORiGO System510(k)Oct 31, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 31, 2022