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Stereotaxis, Inc.

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

Total Devices7
Categories5
Latest FDA decision2026-07-31

SEC Filings: 1 filings on record. Latest: 10-Q (2026-08-12). View on SEC EDGAR →

TypeNumberDevice NameCodeDateActions
PMA P240014 Cardiac ablation percutaneous catheterLPB2026-07-31 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
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