510(k) Report

FDA applicant

Maico Diagnostic GmbH

Eden Prairie, MN1 decision2001–20010 recalls

FDA records 1 decision for Maico Diagnostic GmbH (Eden Prairie, MN) in 2001: 1 510(k) clearance. All are in product code GWJ (Stimulator, Auditory, Evoked Response). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Maico Diagnostic GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Maico Diagnostic GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Maico Diagnostic GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GWJStimulator, Auditory, Evoked Response1decision

What has FDA decided for it lately?

  • K011746MB 11Maico Diagnostic GmbH · 2001

The one decision as Maico Diagnostic GmbH →

Other applicant names beginning “Maico”

FDA records each applicant name separately; these may or may not be the same firm.

Maico Hearing Instruments, Inc. 58Maico Diagnostics GmbH 5Maico Diagnostics (Diagnostic Group, LLC) 1