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Sign in to claim this brandStereotaxis, Inc.
United States·US-MF-000026621
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 710, N. Tucker Blvd, St. Louis, United States
- Website
- stereotaxis.com
- —
- —
- [email protected]
- Phone
- 13146786100
- PRRC Contact
- Matthew Stepanek
- EUDAMED SRN
- US-MF-000026621
- FDA FEI Number
- 3003084417
- DUNS Number
- 024942265
Catalogue (62)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | K193147 | FDA 510(k) | Class II | Active |
| Steerable catheter control system | K183027 | FDA 510(k) | Class II | Active |
| Vdrive W/V-Sono | K122659 | FDA 510(k) | Class II | Active |
| Modification To Endovascular Guide Wire | K043457 | FDA 510(k) | Class II | Active |
| iCONNECT CARTO System Cable | 001-009075-1 | EUDAMED | Class I | Active |
| Odyssey Vision | 001-007010-2 | EUDAMEDFDA UDI | Class I | Active |
| Synchrony | 001-010700-1 | EUDAMED | Class I | Active |
| Odyssey Cinema | 020-007800-4 | EUDAMED | Class I | Active |
| iCONNECT Navistar Catheter Cable | 001-009070-1 | EUDAMED | Class I | Active |
| QuikCAS | 001-001751-1 | EUDAMEDFDA UDI | Class I | Active |
| Helios Ii Ablation Catheter | P050029 | FDA PMA | Class III | Active |
| MAGiC Ablation Catheter | P240014 | FDA PMA | Class III | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (7)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 21, 2020 | Z-0430-2021 | — | terminated | There is a potential for fire in the inside computer cabinet. |
| Jan 27, 2004 | Z-0593-04 | — | terminated | The magnet at the end of the guidewire could break off. |
| Jan 27, 2004 | Z-0592-04 | — | terminated | The magnet at the end of the guidewire could break off. |
| Jan 27, 2004 | Z-0590-04 | — | terminated | The magnet at the end of the guidewire could break off. |
| Jan 27, 2004 | Z-0594-04 | — | terminated | The magnet at the end of the guidewire could break off. |
| Jan 27, 2004 | Z-0591-04 | — | terminated | The magnet at the end of the guidewire could break off. |
| Jan 27, 2004 | Z-0595-04 | — | terminated | The magnet at the end of the guidewire could break off. |