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Stereotaxis, Inc.

28 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Synchrony (K253473)Stereotaxis, Inc.2026-04-01
Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (K251792)Stereotaxis, Inc.2025-11-06
MAGiC Sweep™ EP Mapping Catheter (K250590)Stereotaxis, Inc.2025-07-23
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (K193147)Stereotaxis, Inc.2020-03-05
Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (K192775)Stereotaxis, Inc.2019-10-30
Steerable catheter control system (K183027)Stereotaxis, Inc.2019-09-06
Vdrive system, Vdrive Duo, Vdrive with V-Sono (K150312)Stereotaxis, Inc.2015-06-17
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS (K141530)Stereotaxis, Inc.2014-12-18
VDRIVE WITH V-LOOP/ VDRIVE DUO (K140804)Stereotaxis, Inc.2014-09-03
VDRIVE WITH V-SONO (K133396)Stereotaxis, Inc.2014-02-06
VDRIVE W/V-SONO (K122659)Stereotaxis, Inc.2013-07-26
ODYSSEY WORKSTATION (K093092)Stereotaxis, Inc.2010-01-21
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS (K080637)Stereotaxis, Inc.2008-08-12
ODYSSEY WORKSTATION (K072371)Stereotaxis, Inc.2007-11-14
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) (K071029)Stereotaxis, Inc.2007-08-24
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION (K060967)Stereotaxis, Inc.2006-10-19
CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) (K042850)Stereotaxis, Inc.2006-08-09
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 (K051760)Stereotaxis, Inc.2006-05-05
CRONUS GUIDEWIRE, MODEL 001-001470-1 (K051373)Stereotaxis, Inc.2005-12-09
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (K051374)Stereotaxis, Inc.2005-06-23
MODIFICATION TO ENDOVASCULAR GUIDE WIRE (K043457)Stereotaxis, Inc.2005-02-28
STEREOTAXIS ENDOVASCULAR GUIDE WIRE (K042854)Stereotaxis, Inc.2005-02-08
NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 (K032937)Stereotaxis, Inc.2004-07-01
STEREOTAXIS CATHETER ADVANCER SYSTEM (K021802)Stereotaxis, Inc.2003-04-08
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM (K021555)Stereotaxis, Inc.2003-01-15
ENDOVASCULAR GUIDE WIRE (K021363)Stereotaxis, Inc.2002-11-27
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 (K022565)Stereotaxis, Inc.2002-10-08
TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH (K013484)Stereotaxis, Inc.2002-05-02

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Every clearance here is in the API, with alerts when new ones post.