FDA applicant

Maquet GmbH (A Getinge Group Company)

Rastatt De-Bw, DE1 decision2026–20260 recalls

FDA records 1 decision for Maquet GmbH (A Getinge Group Company) (Rastatt De-Bw, DE) in 2026: 1 510(k) clearance. All are in product code FLE (Sterilizer, Steam). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, general hospital panel, where it files most

How often FDA has decided Maquet GmbH (A Getinge Group Company)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Maquet GmbH (A Getinge Group Company) by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Maquet GmbH (A Getinge Group Company)’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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 Critica Care AB 1

Maquet GmbH (A Getinge Group Company)

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Maquet”