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Stereotaxis, Inc.

FDA 510(k) & PMA Approved Devices — 25 products

Total Devices25
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262744 GenesisX RMNDXX2026-08-27 View
510(k) K253473 SynchronyDQK2026-04-01 View
510(k) K251792 Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)DXX2025-11-06 View
510(k) K250590 MAGiC Sweep™ EP Mapping CatheterDRF2025-07-23 View
510(k) K193147 Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemPJB2020-03-05 View
510(k) K192775 Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriPJB2019-10-30 View
510(k) K183027 Steerable catheter control systemPJB2019-09-06 View
510(k) K122659 VDRIVE W/V-SONODQX2013-07-26 View
510(k) K093092 ODYSSEY WORKSTATIONDQK2010-01-21 View
510(k) K080637 POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUSDQX2008-08-12 View
510(k) K072371 ODYSSEY WORKSTATIONDXX2007-11-14 View
510(k) K071029 CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)DQX2007-08-24 View
510(k) K060967 NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATIONNDQ2006-10-19 View
510(k) K042850 CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)DQY2006-08-09 View
510(k) K051760 NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05DXX2006-05-05 View
510(k) K051373 CRONUS GUIDEWIRE, MODEL 001-001470-1NDQ2005-12-09 View
510(k) K051374 CARDIODRIVE CATHETER ADVANCEMENT SYSTEMDQX2005-06-23 View
510(k) K043457 MODIFICATION TO ENDOVASCULAR GUIDE WIREDQX2005-02-28 View
510(k) K042854 STEREOTAXIS ENDOVASCULAR GUIDE WIREDQX2005-02-08 View
510(k) K032937 NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500DXX2004-07-01 View
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