FDA applicant

Maico Diagnostics (Diagnostic Group, LLC)

Eden Prairie, MN1 decision2007–20070 recalls

FDA records 1 decision for Maico Diagnostics (Diagnostic Group, LLC) (Eden Prairie, MN) in 2007: 1 510(k) clearance. All are in product code EWO (Audiometer). 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, ear, nose and throat panel, where it files most

How often FDA has decided Maico Diagnostics (Diagnostic Group, LLC)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Maico Diagnostics (Diagnostic Group…’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 GmbH 5 Maico Diagnostic GmbH 1

Maico Diagnostics (Diagnostic Group, LLC)

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Maico”