FDA applicant

Ambu, Inc.

Linthicum, MD33 decisions1984–20051 recall

FDA records 33 decisions for Ambu, Inc. (Linthicum, MD) from 1984 to 2005: 33 510(k) clearances. Most are in product codes BTM (Ventilator, Emergency, Manual (Resuscitator)) and GXY (Electrode, Cutaneous). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, anesthesiology panel, where it files most

How often FDA has decided Ambu, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ambu, Inc. since 2007.

Recalls per year

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Ambu”

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

Ambu A/S 41 Ambu Innovation GmbH 1

Ambu, Inc.

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 “Ambu”