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Country not established FDA establishment FEI 3008111228

Devices
0
Registrations
FDA
FDA recalls
55 ongoing

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
3008111228
Address
Landsberger Strasse 65, Germering Bavaria

FDA recalls5

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

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 4
  • 2024 0
  • 2025 1
  • 2026 0

  • 2025

    • 6 Nov 2025 Z-0940-2026 Class II Ongoing Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome. Distribution: Domestic: WI. International: Ireland. Submission number: K100661

  • 2023

    • 26 Sep 2023 Z-0401-2024 Class II Ongoing Affected lots of product may experience technical distortions to a greater extent than expected. Distribution: US States: FL, MO, OH, WI Submission numbers: K133012, K213345
    • 26 Sep 2023 Z-0402-2024 Class II Ongoing Affected lots of product may experience technical distortions to a greater extent than expected. Distribution: US States: FL, MO, OH, WI Submission numbers: K133012, K213345
    • 26 Sep 2023 Z-0403-2024 Class II Ongoing Affected lots of product may experience technical distortions to a greater extent than expected. Distribution: US States: FL, MO, OH, WI Submission numbers: K133012, K213345
    • 26 Sep 2023 Z-0404-2024 Class II Ongoing Affected lots of product may experience technical distortions to a greater extent than expected. Distribution: US States: FL, MO, OH, WI Submission numbers: K133012, K213345

This is an FDA establishment record without devices in deviCERTS.