Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Stereotaxis with 29 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Aug 27, 2026: GenesisX RMN.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 27, 2026 | GenesisX RMNK262744 · DXX | 510(k) clearances |
| Apr 1, 2026 | SynchronyK253473 · DQK | 510(k) clearances |
| Nov 6, 2025 | Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)K251792 · DXX | 510(k) clearances |
| Jul 23, 2025 | MAGiC Sweep™ EP Mapping CatheterK250590 · DRF | 510(k) clearances |
| Sep 21, 2020 | Niobe ES System, Models 001-006000-1 and 001-006100-1Class II · There is a potential for fire in the inside computer cabinet. | Device recalls |
| Mar 5, 2020 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemK193147 · PJB | 510(k) clearances |
| Oct 30, 2019 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriK192775 · PJB | 510(k) clearances |
| Sep 6, 2019 | Steerable catheter control systemK183027 · PJB | 510(k) clearances |
| Jun 17, 2015 | Vdrive system, Vdrive Duo, Vdrive with V-SonoK150312 · DXX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
