FDA applicant

Acarix A/S

Hellerup, DK1 decision2020–20200 recalls

FDA records 1 decision for Acarix A/S (Hellerup, DK) in 2020: 1 De Novo grant. All are in product code QMW (Coronary Artery Disease Risk Indicator From…). 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2020

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Acarix A/S by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Acarix A/S

Which product codes does it file in?

What has FDA decided for it lately?