Stereotaxis, Inc. - FDA 510(k) Cleared Devices
28
Total
28
Cleared
0
Denied
Stereotaxis, Inc. has 28 FDA 510(k) cleared cardiovascular devices. Based in St. Louis, US.
Latest FDA clearance: Apr 2026. Active since 2002.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Access Point Technologies as regulatory consultant.
28 devices
Cleared
Apr 01, 2026
Synchrony
Cardiovascular
173d
Cleared
Nov 06, 2025
Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)
Cardiovascular
148d
Cleared
Jul 23, 2025
MAGiC Sweep™ EP Mapping Catheter
Cardiovascular
146d
Cleared
Mar 05, 2020
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
Cardiovascular
113d
Cleared
Oct 30, 2019
Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and...
Cardiovascular
30d
Cleared
Sep 06, 2019
Steerable catheter control system
Cardiovascular
309d
Cleared
Jun 17, 2015
Vdrive system, Vdrive Duo, Vdrive with V-Sono
Cardiovascular
128d
Cleared
Dec 18, 2014
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
Cardiovascular
192d
Cleared
Sep 03, 2014
VDRIVE WITH V-LOOP/ VDRIVE DUO
Cardiovascular
156d
Cleared
Feb 06, 2014
VDRIVE WITH V-SONO
Cardiovascular
92d
Cleared
Jul 26, 2013
VDRIVE W/V-SONO
Cardiovascular
329d
Cleared
Jan 21, 2010
ODYSSEY WORKSTATION
Cardiovascular
112d