Soterix Medical, 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
SPRY TMS Therapy System (0550)510(k)Feb 20, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 20, 2026
Milieve (YPS-301BD)510(k)Jun 3, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 3, 2024
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)510(k)Mar 25, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 25, 2024
MEGA-TMS510(k)Aug 13, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 13, 2021