FDA applicant

Drager Medical B.V.

Telford, PA2 decisions2006–20135 recalls

FDA records 2 decisions for Drager Medical B.V. (Telford, PA) from 2006 to 2013: 2 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and FTD (Lamp, Surgical). Its devices cite 7 predicates, 0 of them its own earlier devices. 5 recalls are linked to its devices, 3 Class I.

FDA’s records also spell it “Drager Medical GmbH”.

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 Medical B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Drager Medical B.V.’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 “Drager”

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

Drager, Inc. 20 Drager Medizintechnik GmbH 8 Drager Medical AG & Co. Kgaa 3 Drager Safety 1

Drager Medical B.V.

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 “Drager”