Stereotaxis, 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
GenesisX RMN510(k)Aug 27, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Aug 27, 2026
Synchrony510(k)Apr 1, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 1, 2026
Stereotaxis GenesisX RMN with Navigant Workstation (NWS)510(k)Nov 6, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 6, 2025
MAGiC Sweep EP Mapping Catheter510(k)Jul 23, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 23, 2025