Data / Medical devices / United States / Stereotaxis, Inc.
Stereotaxis, Inc.: FDA-registered device maker in Saint Louis, MO, United States, 7 510(k) clearances and 1 PMA approval
Stereotaxis, Inc. is registered with the FDA (registration 3003084417) in Saint Louis, MO, United States. It lists 7 device types. The FDA files 7 510(k) clearances and 1 PMA approval under its listings, the newest dated January 5, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003084417
- Address
- 710 N. Tucker Blvd., Suite 110, Saint Louis, MO, United States, 63101
- Owner or operator
- Stereotaxis (9048165)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 5, 2007
- Registered through
- 2027
- Brand names listed
- Cardiodrive Catheter Advancement Sy, MAGiC Ablation Catheter, Niobe Magnetic Navigation System, Odyssey Cinema, Link, Enterprise, Interface and Studio, Odyssey Workstation, Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (Genesis MNS), Stereotaxis GenesisX RMN with Navigant Workstation (NWS), SynX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cardiac Ablation Percutaneous Catheter | LPB | 3 | Specification developer | accessdata.fda.gov |
| Catheter Remote Control System | PJB | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Catheter Control, Steerable | DXX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Catheter Or Guidewire, Steerable (Magnetic) | NDQ | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 6, 2025 | K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | DXX | Substantially Equivalent | Stereotaxis, Inc. | accessdata.fda.gov |
| March 5, 2020 | K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | PJB | Substantially Equivalent | Stereotaxis, Inc. | accessdata.fda.gov |
| October 30, 2019 | K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri | PJB | Substantially Equivalent | Stereotaxis, Inc. | accessdata.fda.gov |
| June 17, 2015 | K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | DXX | Substantially Equivalent | Stereotaxis, Inc. | accessdata.fda.gov |
| December 18, 2014 | K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | DXX | Substantially Equivalent | Stereotaxis, Inc. | accessdata.fda.gov |
| January 21, 2010 | K093092 | ODYSSEY WORKSTATION | DQK | Substantially Equivalent | Stereotaxis, Inc. | accessdata.fda.gov |
| August 24, 2007 | K071029 | CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) | DQX | Substantially Equivalent | Stereotaxis, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 5, 2026 | P240014 | MAGiC Ablation Catheter | LPB | 1 | July 31, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 21, 2020 | 86555 | Class II | Terminated | Niobe ES System, Models 001-006000-1 and 001-006100-1 | There is a potential for fire in the inside computer cabinet. | accessdata.fda.gov |
| January 27, 2004 | 28254 | Not yet classified | Terminated | Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001096-1 | The magnet at the end of the guidewire could break off. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Catheter Control, Steerable
- All makers of Wire, Guide, Catheter
- All makers of Medical Device Data System
- All makers of Computer, Diagnostic, Programmable
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.