Abmrc, LLC 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
BiWaze Clear System510(k)Aug 24, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Aug 24, 2026
BiWaze Clear System510(k)Apr 8, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Apr 8, 2024
BiWaze Clear System510(k)Dec 21, 2022Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Dec 21, 2022