FDA applicant

Aortech Critical Care, Ltd.

Bellshill, Lanarkshire, GB1 decision2002–20020 recalls

FDA records 1 decision for Aortech Critical Care, Ltd. (Bellshill, Lanarkshire, GB) in 2002: 1 510(k) clearance. All are in product code DFG (Lambda, Rhodamine, Antigen, Antiserum, Control). 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, immunology panel, where it files most

How often FDA has decided Aortech Critical Care, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aortech Critical Care, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aortech Critical Care, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Aortech Critical Care, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?