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Stereotaxis, Inc.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories5
Latest Approval2026-04-01
TypeNumberDevice NameCodeDate
510(k) K253473 Synchrony DQK 2026-04-01 View
PMA P240014 Cardiac ablation percutaneous catheter LPB 2026-01-05 View
510(k) K251792 Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) DXX 2025-11-06 View
510(k) K250590 MAGiC Sweep™ EP Mapping Catheter DRF 2025-07-23 View
510(k) K193147 Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System PJB 2020-03-05 View
510(k) K192775 Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri PJB 2019-10-30 View
510(k) K183027 Steerable catheter control system PJB 2019-09-06 View