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Medtronic Surgical Navigation Technologies

Country not established

Devices
12
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Medtronic Surgical Navigation Technologies makes

The company produces surgical navigation systems and software modules for orthopedic and cardiac procedures, including the StealthStation platform with image-guided and image-less modules for knee and hip surgeries, as well as a cardiac navigation system. Components include magnetic tracking systems, C-arm interfaces, contour registration software, and catheter introducers for intraoperative guidance. Updates and platform expansions are also part of the portfolio.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records in the US. The company is based in the United States.

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

Catalogue12

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FDA recalls1

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

FDA recall records list 1 recall initiated by Medtronic Surgical Navigation Technologies, initiated on 2005-01-28. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware. 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.

  • 2005

    • 28 Jan 2005 Z-0711-05 Unclassified (pre-2012) Terminated The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient. Distribution: Domestic distribution: FL, CO, AZ, TX, AR, MT, OK, IL, PA, NY, LA, WI, NC, ND, CA, GA, AL, OR, WY, WA, OH, NV. Foreign…
      Full distribution text Domestic distribution: FL, CO, AZ, TX, AR, MT, OK, IL, PA, NY, LA, WI, NC, ND, CA, GA, AL, OR, WY, WA, OH, NV. Foreign distribution: Belgium, Czech Republic, China (Malaysia). No military or VA facilites.
      Submission number: K954276

Frequently asked questions

How many devices does Medtronic Surgical Navigation Technologies have in the registry?

The registry currently lists 12 devices for Medtronic Surgical Navigation Technologies. Devices recorded under merged duplicate company entries are counted once.

Which registries list Medtronic Surgical Navigation Technologies's devices?

Among its 12 most recently registered devices, Medtronic Surgical Navigation Technologies has devices listed in FDA 510(k) (12 devices).

What risk classes do Medtronic Surgical Navigation Technologies's devices fall under?

Among its 12 most recently registered devices, the classes recorded for Medtronic Surgical Navigation Technologies's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Medtronic Surgical Navigation Technologies?

FDA recall records list 1 recall initiated by Medtronic Surgical Navigation Technologies, the most recent initiated on 28 Jan 2005. 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 Medtronic Surgical Navigation Technologies in the registry?

The most recently registered devices listed for Medtronic Surgical Navigation Technologies include HIP MODULE FOR THE STEALTHSTATION SYSTEM, MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE, STEALTHSTATION WITH FLUOROMERGE SOFTWARE and IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM.

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