510(k) Report

FDA applicant

Hortmann AG

Dripping Springs, TX2 decisions1998–20000 recalls

FDA records 2 decisions for Hortmann AG (Dripping Springs, TX) from 1998 to 2000: 2 510(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 Hortmann AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hortmann AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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