FDA applicant

Unomedical A/S Infusion Devices

Osted, DK1 decision2012–201210 recalls

FDA records 1 decision for Unomedical A/S Infusion Devices (Osted, DK) in 2012: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). Its devices cite 1 predicate, 0 of them its own earlier devices. 10 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

3in 2014

2012high 7 (2013) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Unomedical A/S Infusion Devices by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Unomedical”

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

Unomedical A/S 13 Unomedical Sdn Bhd 9 Unomedical Devices S.A DE C.V. 1

Unomedical A/S Infusion Devices

Which product codes does it file in?

Whose devices does it build on?

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 “Unomedical”