FDA applicant

Acousticon GmbH

Toms River, NJ1 decision2011–20110 recalls

FDA records 1 decision for Acousticon GmbH (Toms River, NJ) in 2011: 1 510(k) clearance. All are in product code EWO (Audiometer). Its devices cite 1 predicate, 0 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 Acousticon GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Acousticon GmbH by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Acousticon”

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

Acousticon Electronics 1

Acousticon GmbH

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Acousticon”