Onera B.V. 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
Onera SleepMap (SLEEPMAP)510(k)Mar 8, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 8, 2026
Onera STS 2 (ONERA STS 2)510(k)Jul 3, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 3, 2025
Onera Sleep Test System (Onera STS)510(k)Aug 18, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Aug 18, 2023
Onera Sleep Test System (Onera STS)510(k)Apr 6, 2022Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Apr 6, 2022