510(k) Report

FDA applicant

Madsen Electronics, Inc.

Minnetonka, MN4 decisions1995–20000 recalls

FDA records 4 decisions for Madsen Electronics, Inc. (Minnetonka, MN) from 1995 to 2000: 4 510(k) clearances. 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 Madsen Electronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Madsen Electronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Madsen”

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