FDA applicant

Maquet Critica Care AB

Solna, SE1 decision2020–20202 recalls

FDA records 1 decision for Maquet Critica Care AB (Solna, SE) in 2020: 1 510(k) clearance. All are in product code CBK (Ventilator, Continuous, Facility Use). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices, 1 Class I.

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 Maquet Critica Care AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

2in 2022

2020high 2 (2022) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Maquet Critica Care AB by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Maquet”

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

Maquet Cardiopulmonary, AG 44 Maquet Critical Care AB 20 Maquet Cardiovascular, LLC 15 Maquet GmbH 8 Maquet GmbH (A Getinge Group Company) 1

Maquet Critica Care AB

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Maquet”