3B Medical, Inc. 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
Luna G3 BPAP System510(k)Mar 25, 2022Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Mar 25, 2022
Luna® G3 BPAP 25A510(k)Jan 29, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jan 29, 2021