Stereotaxis, Inc.
Medical device manufacturer in St. Louis, MO.
29510(k) clearances
2PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262744 | GenesisX RMNDXX · Special | 08/27/2026SE |
| K253473 | SynchronyDQK · Traditional | 04/01/2026SE |
| K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS)DXX · Traditional | 11/06/2025SE |
| K250590 | MAGiC Sweep EP Mapping CatheterDRF · Traditional | 07/23/2025SE |
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemPJB · Traditional | 03/05/2020SE |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriPJB · Special | 10/30/2019SE |
| K183027 | Steerable catheter control systemPJB · Traditional | 09/06/2019SE |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-SonoDXX · Traditional | 06/17/2015SE |
| K141530 | Vdrive System/ Vdrive Duo/ Vdrive with V-CasDXX · Traditional | 12/18/2014SE |
| K140804 | Vdrive with V-Loop/ Vdrive DuoDXX · Traditional | 09/03/2014SE |
| K133396 | Vdrive with V-SonoDQX · Special | 02/06/2014SE |
| K122659 | Vdrive W/V-SonoDQX · Traditional | 07/26/2013SE |
| K093092 | Odyssey WorkstationDQK · Special | 01/21/2010SE |
| K080637 | Powerasset Radiofrequency Guidwire, Model VariousDQX · Traditional | 08/12/2008SE |
| K072371 | Odyssey WorkstationDXX · Traditional | 11/14/2007SE |
| K071029 | Cardiodrive Catheter Advancement System (Cas)DQX · Traditional | 08/24/2007SE |
| K060967 | Niobe Magnetic Navigation System W/Navigant WorkstationNDQ · Traditional | 10/19/2006SE |
| K042850 | Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile)DQY · Traditional | 08/09/2006SE |
| K051760 | Navigant Workstation with Niobe Magnetic Navigation System, Model NWS05DXX · Traditional | 05/05/2006SE |
| K051373 | Cronus Guidewire, Model 001-001470-1NDQ · Traditional | 12/09/2005SE |
| K051374 | Cardiodrive Catheter Advancement SystemDQX · Special | 06/23/2005SE |
| K043457 | Modification to Endovascular Guide WireDQX · Special | 02/28/2005SE |
| K042854 | Stereotaxis Endovascular Guide WireDQX · Special | 02/08/2005SE |
| K032937 | Navigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500DXX · Traditional | 07/01/2004SE |
| K021802 | Stereotaxis Catheter Advancer SystemDQY · Traditional | 04/08/2003SE |
| K021555 | Stereotaxis Niobe Magnetic Navigation SystemDXX · Traditional | 01/15/2003SE |
| K021363 | Endovascular Guide WireDQX · Traditional | 11/27/2002SE |
| K022565 | Telstar Biplane Digital Imaging System [Tis] Model 030-000915JAA · Special | 10/08/2002SE |
| K013484 | Telstar Magnetic Navigation Systems [Mns}, Telstar Bi-Plane Digital Imaging System…DRF · Traditional | 05/02/2002SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0430-2021 Class II | Niobe ES System, Models 001-006000-1 and 001-006100-1There is a potential for fire in the inside computer cabinet. | 09/21/2020Terminated |