Brainsway , Ltd. FDA Approvals

0 new drug approvals and 7 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
BrainsWay Deep TMS System510(k)Nov 7, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 7, 2025
BrainsWay Deep TMS System510(k)Sep 13, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Sep 13, 2025
Deep TMS System510(k)May 31, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	May 31, 2024
BrainsWay Deep TMS System510(k)Aug 26, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 26, 2022
Deep Transcranial Magnetic Stimulation (DTMS) System510(k)Aug 17, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 17, 2021
Brainsway Deep TMS System510(k)Apr 23, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 23, 2021
Brainsway Deep (DTMS) System510(k)Apr 16, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 16, 2021