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Stereotaxis, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000026621 FEI 3003084417

Stereotaxis, Inc. is a medical device manufacturer based in the United States, with 67 devices listed in 4 registries (FDA Class II, I and III; EU Class I) and 7 FDA recalls as of 13 Nov 2026.

Devices
67
Registrations
EUDAMEDFDA
FDA recalls
7

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 31
  • FDA 510(k) 28
  • EUDAMED 10
  • FDA PMA 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 52
  • EU Class I 8
  • FDA Class I 4
  • FDA Class III 2
  • EU Class IIb 1
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000026621
  • FDA FEI 3003084417
  • DUNS 024942265

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls
Authorised rep.
MDSS GmbHDE

What Stereotaxis, Inc. makes

Stereotaxis, Inc. manufactures cardiac mapping system workstations, robotic surgical navigation systems and associated application software, and neurological stereotactic surgery systems. Their product portfolio includes devices such as the Odyssey Enterprise Interface, V-Sono Intracardiac Echo Manipulator, V-CAS Catheter Advancement System, Cinema MAS & MMS, Cardiodrive System, Niobe MNS Philips, Navigant, QuikCAS Hemostasis Adapter, Vdrive System, V-Loop Variable Loop Catheter Manipulator, and Genesis MNS with Model-S.

The company's devices span Class I, Class II, and Class III regulatory classifications and are listed in the Eudamed, FDA 510(k), FDA PMA, and FDA UDI databases. Stereotaxis, Inc. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue67

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Rows 1-50 of 67

Showing 1-50 of 67

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000026621
FDA FEI number
3003084417
DUNS number
024942265
EUDAMED status
Active
EUDAMED registered name
Stereotaxis, Inc.
Registered address
710, N. Tucker Blvd, 63101, St. Louis, United States
Phone
13146786100
PRRC contact
Matthew Stepanek(public in EUDAMED)

FDA recalls7

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 7 recalls initiated by Stereotaxis, Inc., the earliest on 2004-01-27 and the most recent on 2020-09-21. By recorded status: 7 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 1
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

6 initiated before 2017

  • 2020

    • 21 Sep 2020 Z-0430-2021 Class II Terminated There is a potential for fire in the inside computer cabinet. Distribution: US and OUS distribution: US - TN, MI, MN, KY, MO, IN, TX, NM, CA, NE, OH, NJ, CT, KS, OR, WA, WI, FL, IL, UT, PA, AZ,…
      Full distribution text US and OUS distribution: US - TN, MI, MN, KY, MO, IN, TX, NM, CA, NE, OH, NJ, CT, KS, OR, WA, WI, FL, IL, UT, PA, AZ, NY, GA, ID, OK, CO, LA OUS - EU, China, Australia, Singapore, Canada, South Africa, and Japan
      Submission number: K192775

  • 2004

    • 27 Jan 2004 Z-0590-04 Unclassified (pre-2012) Terminated The magnet at the end of the guidewire could break off. Distribution: The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to…
      Full distribution text The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to consignees in Germany and The Netherlands.
      Submission number: K021363
    • 27 Jan 2004 Z-0591-04 Unclassified (pre-2012) Terminated The magnet at the end of the guidewire could break off. Distribution: The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to…
      Full distribution text The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to consignees in Germany and The Netherlands.
      Submission number: K021363
    • 27 Jan 2004 Z-0592-04 Unclassified (pre-2012) Terminated The magnet at the end of the guidewire could break off. Distribution: The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to…
      Full distribution text The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to consignees in Germany and The Netherlands.
      Submission number: K021363
    • 27 Jan 2004 Z-0593-04 Unclassified (pre-2012) Terminated The magnet at the end of the guidewire could break off. Distribution: The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to…
      Full distribution text The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to consignees in Germany and The Netherlands.
      Submission number: K021363
    • 27 Jan 2004 Z-0594-04 Unclassified (pre-2012) Terminated The magnet at the end of the guidewire could break off. Distribution: The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to…
      Full distribution text The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to consignees in Germany and The Netherlands.
      Submission number: K021363
    • 27 Jan 2004 Z-0595-04 Unclassified (pre-2012) Terminated The magnet at the end of the guidewire could break off. Distribution: The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to…
      Full distribution text The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to consignees in Germany and The Netherlands.
      Submission number: K021363

Frequently asked questions

How many devices does Stereotaxis, Inc. have in the registry?

The registry currently lists 67 devices for Stereotaxis, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Stereotaxis, Inc.'s devices?

Among its 50 most recently registered devices, Stereotaxis, Inc. has devices listed in EUDAMED (4 devices), FDA 510(k) (19 devices) and FDA GUDID (29 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Stereotaxis, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Stereotaxis, Inc.'s devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Stereotaxis, Inc.?

FDA recall records list 7 recalls initiated by Stereotaxis, Inc., the most recent initiated on 21 Sep 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Stereotaxis, Inc. in the registry?

The most recently registered devices listed for Stereotaxis, Inc. include Niobe MNS Omega ES Omega, GenesisX 1, GenesisX RMN and Navigant.

Generated automatically from registry data and not verified by a human reviewer.