Company · US
Stereotaxis, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2026. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (3 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXX | System, Catheter Control, Steerable | 9 |
| DQX | Wire, Guide, Catheter | 8 |
| NFN | 6 | |
| PJB | Catheter Remote Control System | 4 |
| DQK | Computer, Diagnostic, Programmable | 2 |
| DQY | Catheter, Percutaneous | 2 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 |
| NDQ | System, Catheter Or Guidewire, Steerable (Magnetic) | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2026 | K262744 | GenesisX RMN Stereotaxis, Inc. | DXX |
| Apr 1, 2026 | K253473 | Synchrony Stereotaxis, Inc. | DQK |
| Nov 6, 2025 | K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) Stereotaxis, Inc. | DXX |
| Jul 23, 2025 | K250590 | MAGiC Sweep EP Mapping Catheter Stereotaxis, Inc. | DRF |
| Mar 5, 2020 | K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System Stereotaxis, Inc. | PJB |
| Oct 30, 2019 | K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri Stereotaxis, Inc. | PJB |
| Sep 6, 2019 | K183027 | Steerable catheter control system Stereotaxis, Inc. | PJB |
| Jun 17, 2015 | K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono Stereotaxis, Inc. | DXX |
| Dec 18, 2014 | K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS Stereotaxis, Inc. | DXX |
| Sep 3, 2014 | K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO Stereotaxis, Inc. | DXX |
| Feb 6, 2014 | K133396 | VDRIVE WITH V-SONO Stereotaxis, Inc. | DQX |
| Jul 26, 2013 | K122659 | VDRIVE W/V-SONO Stereotaxis, Inc. | DQX |
| Jan 21, 2010 | K093092 | ODYSSEY WORKSTATION Stereotaxis, Inc. | DQK |
| Aug 12, 2008 | K080637 | POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS Stereotaxis, Inc. | DQX |
| Nov 14, 2007 | K072371 | ODYSSEY WORKSTATION Stereotaxis, Inc. | DXX |
| Aug 24, 2007 | K071029 | CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) Stereotaxis, Inc. | DQX |
| Oct 19, 2006 | K060967 | NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION Stereotaxis, Inc. | NDQ |
| Aug 9, 2006 | K042850 | CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) Stereotaxis, Inc. | DQY |
| May 5, 2006 | K051760 | NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 Stereotaxis, Inc. | DXX |
| Dec 9, 2005 | K051373 | CRONUS GUIDEWIRE, MODEL 001-001470-1 Stereotaxis, Inc. | NDQ |
| Jun 23, 2005 | K051374 | CARDIODRIVE CATHETER ADVANCEMENT SYSTEM Stereotaxis, Inc. | DQX |
| Feb 28, 2005 | K043457 | MODIFICATION TO ENDOVASCULAR GUIDE WIRE Stereotaxis, Inc. | DQX |
| Feb 8, 2005 | K042854 | STEREOTAXIS ENDOVASCULAR GUIDE WIRE Stereotaxis, Inc. | DQX |
| Jul 1, 2004 | K032937 | NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 Stereotaxis, Inc. | DXX |
| Apr 8, 2003 | K021802 | STEREOTAXIS CATHETER ADVANCER SYSTEM Stereotaxis, Inc. | DQY |
| Jan 15, 2003 | K021555 | STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM Stereotaxis, Inc. | DXX |
| Nov 27, 2002 | K021363 | ENDOVASCULAR GUIDE WIRE Stereotaxis, Inc. | DQX |
| Oct 8, 2002 | K022565 | TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 Stereotaxis, Inc. | JAA |
| May 2, 2002 | K013484 | TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH Stereotaxis, Inc. | DRF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2020 | Stereotaxis Inc Niobe ES System, Models 001-006000-1 and 001-006100-1 Terminated |
PJB | K192775 |
| Jul 20, 2004 | Stereotaxis Inc Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1 Terminated |
NFN | K021363 |
| Jul 20, 2004 | Stereotaxis Inc Floppy Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-4 Terminated |
NFN | K021363 |
| Jul 20, 2004 | Stereotaxis Inc Floppy Cronus Endovascular Guidewire, Length 180 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-3 Terminated |
NFN | K021363 |
| Jul 20, 2004 | Stereotaxis Inc Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-4 Terminated |
NFN | K021363 |
| Jul 20, 2004 | Stereotaxis Inc Cronus Endovascular Guidewire, Length 210 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-3 Terminated |
NFN | K021363 |
| Jul 20, 2004 | Stereotaxis Inc Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001096-1 Terminated |
NFN | K021363 |