Neuroone Medical Technologies Corp. 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
OneRF Trigeminal Nerve Radiofrequency Probes510(k)Aug 15, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 15, 2025
OneRF Ablation System510(k)Dec 6, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Dec 6, 2023
Evo® sEEG System510(k)Oct 20, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 20, 2022
Evo sEEG System510(k)Sep 1, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Sep 1, 2021