FDA applicant

Drager Medizintechnik GmbH

Telford, PA8 decisions1999–20038 recalls

FDA records 8 decisions for Drager Medizintechnik GmbH (Telford, PA) from 1999 to 2003: 8 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and FSY (Light, Surgical, Ceiling Mounted). Its devices cite 2 predicates, 2 of them its own earlier devices. 8 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, anesthesiology panel, where it files most

How often FDA has decided Drager Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Drager Medizintechnik GmbH since 2007.

Recalls per year

1in 2014

2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Drager”

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

Drager, Inc. 20 Drager Medical AG & Co. Kgaa 3 Drager Medical B.V. 2 Drager Safety 1

Drager Medizintechnik GmbH

Which product codes does it file in?

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 “Drager”