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Stereotaxis, Inc.

United States·US-MF-000026621

Last updated September 17, 2026

Information

Country: United States
Address: 710, N. Tucker Blvd, St. Louis, United States
Website: stereotaxis.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 13146786100
PRRC Contact: Matthew Stepanek
EUDAMED SRN: US-MF-000026621
FDA FEI Number: 3003084417
DUNS Number: 024942265

Catalogue (62)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Odyssey Enterprise Interface	EIF	FDA UDI	Class I	Active
V-Sono Intracardiac Echo Manipulator	1	FDA UDI	Class II	Active
V-CAS Catheter Advancement System	1	FDA UDI	Class II	Active
Cinema MAS & MMS	DMS-100	FDA UDI	Class I	Active
Cardiodrive System	II	FDA UDI	Class II	Active
Niobe MNS Philips	ES Philips	FDA UDI	Class II	Active
Navigant	4.6.5	FDA UDI	Class II	Active
QuikCAS Hemostasis Adapter	1	FDA UDI	Class II	Active
Vdrive System	Duo	FDA UDI	Class II	Active
V-Loop Variable Loop Catheter Manipulator	1	FDA UDI	Class II	Active
Vdrive System	Single Arm	FDA UDI	Class II	Active
Genesis MNS with Model-S	1.1 Model-S	FDA UDI	Class II	Active
Navigant	4.6.4	FDA UDI	Class II	Active
Navigant	5.0.7	FDA UDI	Class II	Active
Cardiodrive System	II	FDA UDI	Class II	Active
Cardiodrive System	II	FDA UDI	Class II	Active
Niobe MNS Siemens	ES Siemens	FDA UDI	Class II	Active
Vdrive Drape	1	FDA UDI	Class II	Unknown
Odyssey Cinema	Studio	FDA UDI	Class I	Active
Cardiodrive Hemostasis Adapter - SJ	1	FDA UDI	Class II	Active
Odyssey	Link	FDA UDI	Class I	Active
Genesis (RMNS)	1.1	FDA UDI	Class II	Active
Navigant	5.0.2	FDA UDI	Class II	Active
Niobe Cover Drape	1	FDA UDI	Class II	Unknown
Navigant	5.1.0	FDA UDI	Class II	Active
Hemostasis Adapter	IV-1	FDA UDI	Class II	Active
SynX	001-014800-1	EUDAMED	Class I	Active
Telstar Biplane Digital Imaging System [tis] Model 030-000915	K022565	FDA 510(k)	Class II	Active
Cardiodrive Catheter Advancement System	K051374	FDA 510(k)	Class II	Active
Stereotaxis Endovascular Guide Wire	K042854	FDA 510(k)	Class II	Active
Navigant Magnetic Navigation Workstation 2.1 (nws2) Model, 020-004500	K032937	FDA 510(k)	Class II	Active
Navigant Workstation With Niobe Magnetic Navigation System, Model Nws05	K051760	FDA 510(k)	Class II	Active
Cronus Guidewire, Model 001-001470-1	K051373	FDA 510(k)	Class II	Active
Vdrive System/ Vdrive Duo/ Vdrive With V-Cas	K141530	FDA 510(k)	Class II	Active
Stereotaxis Catheter Advancer System	K021802	FDA 510(k)	Class II	Active
Stereotaxis Niobe Magnetic Navigation System	K021555	FDA 510(k)	Class II	Active
Telstar Magnetic Navigation Systems [mns}, Telstar Bi-Plane Digital Imaging System, Niobe Electrophysiology Mapping Cath	K013484	FDA 510(k)	Class II	Active
Cardiodrive Catheter Advancement System (cas)	K071029	FDA 510(k)	Class II	Active
Vdrive system, Vdrive Duo, Vdrive with V-Sono	K150312	FDA 510(k)	Class II	Active
MAGiC Sweep™ EP Mapping Catheter	K250590	FDA 510(k)	Class II	Active
Endovascular Guide Wire	K021363	FDA 510(k)	Class II	Active
Odyssey Workstation	K093092	FDA 510(k)	Class II	Active
Vdrive With V-Sono	K133396	FDA 510(k)	Class II	Active
Niobe Magnetic Navigation System W/Navigant Workstation	K060967	FDA 510(k)	Class II	Active
Odyssey Workstation	K072371	FDA 510(k)	Class II	Active
Vdrive With V-Loop/ Vdrive Duo	K140804	FDA 510(k)	Class II	Active
Cardiodrive, Model 001-004115 (non-Sterile); 001-1169-1 (sterile)	K042850	FDA 510(k)	Class II	Active
Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri	K192775	FDA 510(k)	Class II	Active
Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)	K251792	FDA 510(k)	Class II	Active
Powerasset Radiofrequency Guidwire, Model Various	K080637	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (7)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 21, 2020	Z-0430-2021	—	terminated	There is a potential for fire in the inside computer cabinet.
Jan 27, 2004	Z-0593-04	—	terminated	The magnet at the end of the guidewire could break off.
Jan 27, 2004	Z-0592-04	—	terminated	The magnet at the end of the guidewire could break off.
Jan 27, 2004	Z-0590-04	—	terminated	The magnet at the end of the guidewire could break off.
Jan 27, 2004	Z-0594-04	—	terminated	The magnet at the end of the guidewire could break off.
Jan 27, 2004	Z-0591-04	—	terminated	The magnet at the end of the guidewire could break off.
Jan 27, 2004	Z-0595-04	—	terminated	The magnet at the end of the guidewire could break off.