FDA applicant

Dragerwerk AG

Mchenry, IL3 decisions1980–19910 recalls

FDA records 3 decisions for Dragerwerk AG (Mchenry, IL) from 1980 to 1991: 3 510(k) clearances. Most are in product codes FMZ (Incubator, Neonatal) and KLK (Monitor, Oxygen, Cutaneous, For Infant Not…). 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 Dragerwerk AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dragerwerk AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Dragerwerk”

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

Drägerwerk AG & Co. KGaA 7

Dragerwerk AG

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Dragerwerk”