FDA applicant

Biometer Intl. A/S

Denmark, DK9 decisions1986–19930 recalls

FDA records 9 decisions for Biometer Intl. A/S (Denmark, DK) from 1986 to 1993: 9 510(k) clearances. Most are in product codes BXN (Stimulator, Nerve, Battery-Powered) and IPF (Stimulator, Muscle, Powered). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Biometer Intl. A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Biometer Intl. A/S

Which product codes does it file in?

What has FDA decided for it lately?