FDA applicant

Odi Medical AS

Oslo, NO1 decision2024–20240 recalls

FDA records 1 decision for Odi Medical AS (Oslo, NO) in 2024: 1 510(k) clearance. All are in product code MUD (Oximeter, Tissue Saturation). 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 Odi Medical AS’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Odi Medical AS by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Odi Medical AS

Which product codes does it file in?

What has FDA decided for it lately?