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Dixtal Medical, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
2
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Dixtal Medical, Inc. makes

Dixtal Medical, Inc. manufactures pulse oximeters, including the DZ-4100 series, and disposable finger sensors for non-invasive blood oxygen monitoring. These devices are designed for clinical and home-use settings to measure oxygen saturation levels in patients.

The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance process. The manufacturer operates from the United States.

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

Catalogue2

Newest first, rows 1-2 of 2

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 3 recalls initiated by Dixtal Medical, Inc., the earliest on 2009-05-13 and the most recent on 2010-09-27. By recorded status: 3 terminated. The reasons filed fall into these groups: labeling or instructions for use and packaging. 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.

  • 2010

    • 27 Sep 2010 Z-0550-2011 Unclassified (pre-2012) Terminated Unit may overestimate Sp02 levels in a high humidity environment. Distribution: Worldwide Distribution -- USA, including states of AK, KY, NJ, and NY and countries of Australia, Austria, Bolivia,…
      Full distribution text Worldwide Distribution -- USA, including states of AK, KY, NJ, and NY and countries of Australia, Austria, Bolivia, Canada, Finland, Indonesia, Italy, Poland, Sweden, and Switzerland.
      Submission number: K032949
    • 27 Sep 2010 Z-0551-2011 Unclassified (pre-2012) Terminated Unit may overestimate Sp02 levels in a high humidity environment. Distribution: Worldwide Distribution -- USA, including states of AK, KY, NJ, and NY and countries of Australia, Austria, Bolivia,…
      Full distribution text Worldwide Distribution -- USA, including states of AK, KY, NJ, and NY and countries of Australia, Austria, Bolivia, Canada, Finland, Indonesia, Italy, Poland, Sweden, and Switzerland.
      Submission number: K032949

  • 2009

    • 13 May 2009 Z-1559-2009 Unclassified (pre-2012) Terminated Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors. Distribution: Worldwide Distribution -- US (TX and CT) and countries of Italy, Japan, France and Turkey. Submission number: K913516

Frequently asked questions

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

The registry currently lists 2 devices for Dixtal Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Dixtal Medical, Inc.'s devices?

Among its 2 most recently registered devices, Dixtal Medical, Inc. has devices listed in FDA 510(k) (2 devices).

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

Among its 2 most recently registered devices, the classes recorded for Dixtal Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Dixtal Medical, Inc.?

FDA recall records list 3 recalls initiated by Dixtal Medical, Inc., the most recent initiated on 2010-09-27. 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 Dixtal Medical, Inc. in the registry?

The most recently registered devices listed for Dixtal Medical, Inc. include DIXTAL DZ-4100 SERIES PULSE OXIMETER and DX SERIES FINGER SENSOR.

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