510(k) Report

FDA applicant

Bmc Gesellschaft Fur Medizintechnik Mbh

Hamburg, DE1 decision2006–20060 recalls

FDA records 1 decision for Bmc Gesellschaft Fur Medizintechnik Mbh (Hamburg, DE) in 2006: 1 510(k) clearance. All are in product code MWI (Monitor, Physiological, Patient (Without…). 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, cardiovascular panel, where it files most

How often FDA has decided Bmc Gesellschaft Fur Medizintechnik Mbh’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bmc Gesellschaft Fur Medizintechnik Mbh since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K060756Medlog, Model 1-0-10Bmc Gesellschaft Fur Medizintechnik Mbh · 2006

The one decision as Bmc Gesellschaft Fur Medizintechnik Mbh →