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VitreQ BV

NetherlandsFDA 510(k) applicant, unverified FDA FEI 3012037425

Devices
1
Registrations
FDA
FDA recalls
16

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

What VitreQ BV makes

VitreQ BV manufactures single-use laser probes, light fibers, and a Chandelier device designed for ophthalmic surgical procedures, specifically for vitreoretinal applications.

These products are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.

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

Catalogue1

Newest first, rows 1-1 of 1

Company details

FDA FEI number
3012037425
Address
Seggelant-Noord 2, Vierpolders Zuid-Holland

FDA recalls16

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

FDA recall records list 16 recalls initiated by VitreQ BV, initiated on 2019-12-17. By recorded status: 16 terminated. The reasons filed fall into these groups: sterility or contamination 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.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 16
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

Showing the 10 most recent of 16 recalls.

  • 2019

    • 17 Dec 2019 Z-0846-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0847-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0848-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0849-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0850-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0851-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0852-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0853-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0854-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0855-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
Show all 16 recalls

  • 2019

    • 17 Dec 2019 Z-0856-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0857-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0858-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0859-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0860-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide
    • 17 Dec 2019 Z-0861-2020 Class II Terminated Microscopic tears of the sterile pouch may compromise sterility Distribution: Nationwide

Frequently asked questions

How many devices does VitreQ BV have in the registry?

The registry currently lists 1 device for VitreQ BV. Devices recorded under merged duplicate company entries are counted once.

Which registries list VitreQ BV's devices?

Among its 1 most recently registered device, VitreQ BV has devices listed in FDA 510(k) (1 device).

What risk classes do VitreQ BV's devices fall under?

Among its 1 most recently registered device, the classes recorded for VitreQ BV's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for VitreQ BV?

FDA recall records list 16 recalls initiated by VitreQ BV, the most recent initiated on 2019-12-17. 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 VitreQ BV in the registry?

The most recently registered devices listed for VitreQ BV include Vitreq disposable laser probes, light fibers and Chandelier.

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