FDA applicant

Interacoustics AS

Assens, DK4 decisions2005–20090 recalls

FDA records 4 decisions for Interacoustics AS (Assens, DK) from 2005 to 2009: 4 510(k) clearances. Most are in product codes EWO (Audiometer) and ETY (Tester, Auditory Impedance). Its devices cite 2 predicates, 1 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 Interacoustics AS’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Interacoustics AS’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Interacoustics”

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

Interacoustics A/S 17 Interacoustics A/S, Assens 4

Interacoustics AS

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Interacoustics”