Company

Stereotaxis

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About

Makes robotic systems for endovascular procedures in interventional medicine, including cardiac ablation.

No machines listed yet

FDA 510(k) clearance K262744: GenesisX RMN
U.S. FDA27 Aug 2026
FDA 510(k) clearance K251792: Stereotaxis GenesisX RMN with Navigant Workstation (NWS)
U.S. FDA6 Nov 2025
FDA 510(k) clearance K193147: Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
U.S. FDA5 Mar 2020
FDA 510(k) clearance K192775: Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
U.S. FDA30 Oct 2019
FDA 510(k) clearance K183027: Steerable catheter control system
U.S. FDA6 Sept 2019

11 older official filings

FDA 510(k) clearance K150312: Vdrive system, Vdrive Duo, Vdrive with V-Sono
U.S. FDA17 Jun 2015
FDA 510(k) clearance K141530: VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
U.S. FDA18 Dec 2014
FDA 510(k) clearance K140804: VDRIVE WITH V-LOOP/ VDRIVE DUO
U.S. FDA3 Sept 2014
FDA 510(k) clearance K072371: ODYSSEY WORKSTATION
U.S. FDA14 Nov 2007
FDA 510(k) clearance K060967: NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
U.S. FDA19 Oct 2006
FDA 510(k) clearance K042850: CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)
U.S. FDA9 Aug 2006
FDA 510(k) clearance K051760: NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05
U.S. FDA5 May 2006
FDA 510(k) clearance K051373: CRONUS GUIDEWIRE, MODEL 001-001470-1
U.S. FDA9 Dec 2005
FDA 510(k) clearance K032937: NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500
U.S. FDA1 Jul 2004
FDA 510(k) clearance K021802: STEREOTAXIS CATHETER ADVANCER SYSTEM
U.S. FDA8 Apr 2003
FDA 510(k) clearance K021555: STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
U.S. FDA15 Jan 2003

Stereotaxis