FDA applicant

Interacoustics A/S

Middelfart, DK17 decisions2006–20200 recalls

FDA records 17 decisions for Interacoustics A/S (Middelfart, DK) from 2006 to 2020: 17 510(k) clearances. Most are in product codes GWN (Nystagmograph) and EWO (Audiometer). Its devices cite 24 predicates, 6 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, neurology panel, where it files most

How often FDA has decided Interacoustics A/S’s devices, and how often a recall has named them.

FDA decisions per year

3in 2020

2007high 3 (2020) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Interacoustics A/S’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 AS 4 Interacoustics A/S, Assens 4

Interacoustics A/S

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”