FDA applicant

Maico Diagnostics GmbH

Berlin, DE5 decisions2001–20170 recalls

FDA records 5 decisions for Maico Diagnostics GmbH (Berlin, DE) from 2001 to 2017: 5 510(k) clearances. Most are in product codes EWO (Audiometer) and ETY (Tester, Auditory Impedance). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Maico-Diagnostics”, “Maico Diagnostics”.

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

FIG. A — Illustration, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2017

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Maico Diagnostics GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Maico”

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

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

Maico Diagnostics GmbH

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Maico”