Stereotaxis Inc

FDA Filings

This page includes the latest FDA filings for Stereotaxis Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USAAMEXSTXSDUNS 024942265
FDA Registration(s)
Registration Number3003084417
FEI Number3003084417
NameSTEREOTAXIS, INC.
Owner & OperatorSTEREOTAXIS, INC.
Contact Address4320 FOREST PARK AVENUE SUITE 100
Saint Louis MO 63108 US
Official Correspondent
  • Kenneth H Lock
  • x-314-6786123-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4320 FOREST PARK AVENUE SUITE 100
Saint Louis, MO 63108 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
STEREOTAXIS, INC.
Navigant 020-004500-372023-05-03
STEREOTAXIS, INC.
Cardiodrive System 001-004115-122022-06-14
STEREOTAXIS, INC.
Cardiodrive System 001-004115-112022-06-14
STEREOTAXIS, INC.
Hemostasis Adapter 00100111412021-12-22
STEREOTAXIS, INC.
Genesis MNS with Model-S 001-011000-32020-08-28
STEREOTAXIS, INC.
Genesis (MNS) with Siemens 001-011000-12020-08-28
Stereotaxis, Inc.
Stereotaxis Genesis RMN With Navigant Workstation (NWS) And Cardiodrive System2020-03-05
Stereotaxis, Inc.
Niobe® Magnetic Navigation System (MNS) With Navigant Workstation (NWS) And Cardiodri2019-10-30
Stereotaxis, Inc.
Steerable Catheter Control System2019-09-06
STEREOTAXIS, INC.
Odyssey Workstation2018-12-14
STEREOTAXIS, INC.
Vdrive System, Vdrive Duo, Vdrive With V-Sono2015-06-17
STEREOTAXIS, INC.
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS2014-12-18
STEREOTAXIS, INC.
VDRIVE WITH V-LOOP/ VDRIVE DUO2014-09-03
STEREOTAXIS, INC.
VDRIVE WITH V-SONO2014-02-06
STEREOTAXIS, INC.
Vdrive2013-09-06
STEREOTAXIS, INC.
Vdrive with V-Sono2013-09-06
STEREOTAXIS, INC.
V-Sono2013-09-06
STEREOTAXIS, INC.
V-Sono Intracardiac Echocardiography Catheter2013-09-06
STEREOTAXIS, INC.
V-Sono Intracardiac Echocardiography Catheter (ICE)2013-09-06
STEREOTAXIS, INC.
Vdrive2013-09-06
STEREOTAXIS, INC.
Vdrive with V-Sono2013-09-06
STEREOTAXIS, INC.
V-Sono2013-09-06
STEREOTAXIS, INC.
V-Sono Intracardiac Echocardiography Catheter2013-09-06
STEREOTAXIS, INC.
V-Sono Intracardiac Echocardiography Catheter (ICE)2013-09-06
STEREOTAXIS, INC.
VDRIVE W/V-SONO2013-07-26
STEREOTAXIS, INC.
Odyssey Cinema, Link, Enterprise, Interface and Studio2011-06-09
STEREOTAXIS, INC.
ODYSSEY WORKSTATION2010-01-21
STEREOTAXIS, INC.
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS2008-08-12
STEREOTAXIS, INC.
Odyssey Workstation2007-12-05
STEREOTAXIS, INC.
Cardiodrive Catheter Advancement Sy2007-12-05
STEREOTAXIS, INC.
Niobe Magnetic Navigation System2007-12-05
STEREOTAXIS, INC.
ODYSSEY WORKSTATION2007-11-14
STEREOTAXIS, INC.
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)2007-08-24
STEREOTAXIS, INC.
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION2006-10-19
STEREOTAXIS, INC.
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS052006-05-05
STEREOTAXIS, INC.
CRONUS GUIDEWIRE, MODEL 001-001470-12005-12-09
STEREOTAXIS, INC.
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM2005-06-23
STEREOTAXIS, INC.
MODIFICATION TO ENDOVASCULAR GUIDE WIRE2005-02-28
STEREOTAXIS, INC.
STEREOTAXIS ENDOVASCULAR GUIDE WIRE2005-02-08
STEREOTAXIS, INC.
NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-0045002004-07-01
STEREOTAXIS, INC.
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM2003-01-15
STEREOTAXIS, INC.
ENDOVASCULAR GUIDE WIRE2002-11-27
STEREOTAXIS, INC.
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-0009152002-10-08
STEREOTAXIS, INC.
TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH2002-05-02

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019020930830Singapore,Singapore -> New York/Newark Area, Newark, New JerseyTOOLS FOR MEDICAL EQUIPMENT INSTALL INVOICE NO. 904 (5 UNITS) HS CODE: 90189090 . . .5 CRT

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