Stereotaxis, Inc. - FDA 510(k) Cleared Devices
27
Total
27
Cleared
0
Denied
FDA 510(k) cleared devices by Stereotaxis, Inc. Cardiovascular ✕
24 devices
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
Cleared
Aug 12, 2008
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
Cardiovascular
159d