510(k) Report

FDA applicant

Entomed AB

Malmo, SE1 decision2009–20090 recalls

FDA records 1 decision for Entomed AB (Malmo, SE) in 2009: 1 510(k) clearance. 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 Entomed AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Entomed AB by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EWOAudiometer1decision

What has FDA decided for it lately?

  • K092111Entomed Screening Audiometer, Model SA201,SA202, Entomed Diagnostic Audiometer Model SA203,SA204Entomed AB · 2009

The one decision as Entomed AB →