FDA applicant

Radiometer Medical A/S

Bronshoj, DK2 decisions2000–200012 recalls

FDA records 2 decisions for Radiometer Medical A/S (Bronshoj, DK) in 2000: 2 510(k) clearances. Most are in product codes CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…) and LPP (Monitor, Oxygen, Cutaneous, For Uses Other…). 12 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Radiometer Medical A/S since 2007.

Recalls per year

1in 2020

2007high 4 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Radiometer”

FDA records each applicant name separately; these may or may not be the same firm.

Radiometer America, Inc. 50 Radiometer Medical Aps 28 Radiometer Medicals Aps 5 Radiometer Basel AG 1

Radiometer Medical A/S

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Radiometer”