STEREOTAXIS, INC.

Matched from indexed company URL: Stereotaxis, Inc.

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3003084417	3003084417	STEREOTAXIS, INC.	1	N	2026-01-01	710 N. Tucker Blvd., Suite 110 Saint Louis MO US 63101

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
59831	1856688661	P240014			1969-12-31
59831	1079046906	K251792	Stereotaxis GenesisX RMN with Navigant Workstation (NWS)	DXX	2025-11-06
59831	1291271560	K193147	Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System	PJB	2020-03-05
59831	1086521175	K192775	Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri	PJB	2019-10-30
59831	1753160422	K150312	Vdrive system, Vdrive Duo, Vdrive with V-Sono	DXX	2015-06-17
59831	1503724748	K141530	VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS	DXX	2014-12-18
59831	2031835693	K140804	VDRIVE WITH V-LOOP/ VDRIVE DUO	DXX	2014-09-03
59831	1045182920	K133396	VDRIVE WITH V-SONO	DQX	2014-02-06
59831	1638739304	K122659	VDRIVE W/V-SONO	DQX	2013-07-26
59831	1606842181	K093092	ODYSSEY WORKSTATION	DQK	2010-01-21
59831	2051785781	K072371	ODYSSEY WORKSTATION	DXX	2007-11-14
59831	1666462778	K071029	CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)	DQX	2007-08-24
59831	1471315869	K060967	NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION	NDQ	2006-10-19
59831	1895911417

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
DXX	5	2025-11-06
DQX	3	2014-02-06
PJB	2	2020-03-05
DQK	1	2010-01-21
NDQ	1	2006-10-19

PMN

Stereotaxis Genesis RMN With Navigant Workstation (NWS) And Cardiodrive System

2020-03-05

Stereotaxis, Inc.

Niobe® Magnetic Navigation System (MNS) With Navigant Workstation (NWS) And Cardiodri

2019-10-30

Stereotaxis, Inc.

Steerable Catheter Control System

2019-09-06

Stereotaxis, Inc.

Vdrive System, Vdrive Duo, Vdrive With V-Sono

2015-06-17

STEREOTAXIS, INC.

VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS

2014-12-18

STEREOTAXIS, INC.

VDRIVE WITH V-LOOP/ VDRIVE DUO

2014-09-03

STEREOTAXIS, INC.

VDRIVE WITH V-SONO

2014-02-06

STEREOTAXIS, INC.

VDRIVE W/V-SONO

2013-07-26

STEREOTAXIS, INC.

ODYSSEY WORKSTATION

2010-01-21

STEREOTAXIS, INC.

POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS

2008-08-12

STEREOTAXIS, INC.

ODYSSEY WORKSTATION

2007-11-14

STEREOTAXIS, INC.

CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)

2007-08-24

STEREOTAXIS, INC.

NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION

2006-10-19

STEREOTAXIS, INC.

NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05

2006-05-05

STEREOTAXIS, INC.

CRONUS GUIDEWIRE, MODEL 001-001470-1

2005-12-09

STEREOTAXIS, INC.

CARDIODRIVE CATHETER ADVANCEMENT SYSTEM

2005-06-23

STEREOTAXIS, INC.

MODIFICATION TO ENDOVASCULAR GUIDE WIRE

2005-02-28

STEREOTAXIS, INC.

STEREOTAXIS ENDOVASCULAR GUIDE WIRE

2005-02-08

STEREOTAXIS, INC.

NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500

2004-07-01

STEREOTAXIS, INC.

STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM

2003-01-15

STEREOTAXIS, INC.

ENDOVASCULAR GUIDE WIRE

2002-11-27

STEREOTAXIS, INC.

TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915

2002-10-08

STEREOTAXIS, INC.

TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH

2002-05-02

STEREOTAXIS, INC.

GUDID

GenesisX

2026-01-09

Stereotaxis, Inc.

Navigant

2023-04-25

STEREOTAXIS, INC.

Cardiodrive System

2022-06-06

STEREOTAXIS, INC.

Navigant

2022-06-06

Stereotaxis, Inc.

Cardiodrive System

2022-06-06

STEREOTAXIS, INC.

Hemostasis Adapter

2021-12-14

STEREOTAXIS, INC.

Genesis (MNS) with Siemens

2020-08-20

STEREOTAXIS, INC.

Genesis MNS with Model-S

2020-08-20

STEREOTAXIS, INC.

Navigant

2016-10-27

Stereotaxis, Inc.

Cardiodrive Hemostasis Adapter - SJ

2016-08-01

Stereotaxis, Inc.

Vdrive System

2016-08-01

Stereotaxis, Inc.

Vdrive System

2016-08-01

Stereotaxis, Inc.

Vdrive Drape

2016-08-01

Stereotaxis, Inc.

QuikCAS Hemostasis Adapter

2016-08-01

Stereotaxis, Inc.

Odyssey Enterprise Interface

2016-08-01

Stereotaxis, Inc.

Odyssey Cinema

2016-08-01

Stereotaxis, Inc.

Odyssey

2016-08-01

Stereotaxis, Inc.

Odyssey

2016-08-01

Stereotaxis, Inc.

Niobe MNS Siemens

2016-08-01

Stereotaxis, Inc.

Niobe MNS Philips

2016-08-01

Stereotaxis, Inc.

Niobe Cover Drape

2016-08-01

Stereotaxis, Inc.

Navigant

2016-08-01

Stereotaxis, Inc.

Navigant

2016-08-01

Stereotaxis, Inc.

Cardiodrive System

2016-08-01

Stereotaxis, Inc.

QuikCAS Cardiodrive Sterile Components

2016-05-02

Stereotaxis, Inc.

V-CAS Catheter Advancement System

2016-05-02

Stereotaxis, Inc.

V-Loop Variable Loop Catheter Manipulator

2016-05-02

Stereotaxis, Inc.

V-Sono Intracardiac Echo Manipulator

2016-05-02

Stereotaxis, Inc.