Auris Health, Inc. FDA Approvals

0 new drug approvals and 4 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
MONARCH Platform (MON-000008)510(k)Jul 25, 2026Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jul 25, 2026
MONARCH Platform (MON-000008)510(k)Jan 23, 2025Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jan 23, 2025
Monarch Platform, Urology510(k)Apr 29, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Apr 29, 2022
Monarch Platform510(k)Jul 9, 2021Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Special)	Jul 9, 2021