FDA applicant

Bernafon-Maico, Inc.

Eden Prairie, MN9 decisions1996–19980 recalls

FDA records 9 decisions for Bernafon-Maico, Inc. (Eden Prairie, MN) from 1996 to 1998: 9 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and 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 Bernafon-Maico, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bernafon-Maico, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bernafon-Maico, Inc.’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 “Bernafon-Maico”

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

Bernafon, Inc. 16

Bernafon-Maico, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Bernafon-Maico”