FDA applicant

Gn Danavox, Inc.

Minnetonka, MN10 decisions1986–19970 recalls

FDA records 10 decisions for Gn Danavox, Inc. (Minnetonka, MN) from 1986 to 1997: 10 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and ETW (Calibrator, Hearing Aid / Earphone And…). Its devices cite 2 predicates, 2 of them its own earlier devices. 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 Gn Danavox, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gn Danavox, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Gn Danavox, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?