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MINDRAY DS USA, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 2221819

Devices
3
Registrations
FDA
FDA recalls
88 ongoing

What MINDRAY DS USA, Inc. makes

MINDRAY DS USA, Inc. manufactures patient monitoring systems, including the V Series (12.1 DCU/V12 and 21.0 DCU/V21) and the Endeavour Monitoring System, as well as the AS3700 Anesthesia Delivery System for clinical use in operating rooms and critical care settings.

These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. The company is based in the United States.

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

Catalogue3

Newest first, rows 1-3 of 3

Company details

FDA FEI number
2221819
Address
800 MACARTHUR BLVD., Mahwah, NJ, 07430

FDA recalls8

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

FDA recall records list 8 recalls initiated by MINDRAY DS USA, Inc., initiated on 2026-08-31. By recorded status: 8 ongoing. The reasons filed fall into these groups: labeling or instructions for use and electrical or power. 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 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 8

  • 2026

    • 31 Aug 2026 Z-0109-2027 Class III Ongoing Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Distribution: Worldwide - Nationwide and the country of Canada. Submission number: K260098
    • 31 Aug 2026 Z-0110-2027 Class III Ongoing Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Distribution: Worldwide - Nationwide and the country of Canada. Submission number: K213799
    • 31 Aug 2026 Z-0111-2027 Class III Ongoing Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Distribution: Worldwide - Nationwide and the country of Canada. Submission number: K242728
    • 31 Aug 2026 Z-0112-2027 Class III Ongoing Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Distribution: Worldwide - Nationwide and the country of Canada. Submission number: K242728
    • 31 Aug 2026 Z-0113-2027 Class III Ongoing Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Distribution: Worldwide - Nationwide and the country of Canada. Submission number: K092449
    • 31 Aug 2026 Z-0114-2027 Class III Ongoing Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Distribution: Worldwide - Nationwide and the country of Canada. Submission numbers: K153448, K190011
    • 31 Aug 2026 Z-0115-2027 Class III Ongoing Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Distribution: Worldwide - Nationwide and the country of Canada. Submission number: K153448
    • 31 Aug 2026 Z-0116-2027 Class III Ongoing Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Distribution: Worldwide - Nationwide and the country of Canada. Submission number: K190011

Frequently asked questions

How many devices does MINDRAY DS USA, Inc. have in the registry?

The registry currently lists 3 devices for MINDRAY DS USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list MINDRAY DS USA, Inc.'s devices?

Among its 3 most recently registered devices, MINDRAY DS USA, Inc. has devices listed in FDA 510(k) (3 devices).

What risk classes do MINDRAY DS USA, Inc.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for MINDRAY DS USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for MINDRAY DS USA, Inc.?

FDA recall records list 8 recalls initiated by MINDRAY DS USA, Inc., the most recent initiated on 31 Aug 2026. 8 of them are recorded as ongoing. 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 MINDRAY DS USA, Inc. in the registry?

The most recently registered devices listed for MINDRAY DS USA, Inc. include V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21, AS3700 ANESTHSIA DELIVERY SYSTEM and ENDEAVOUR MONITORING SYSTEM.

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

This is an FDA establishment record. No EUDAMED registration is known for this company.