FDA applicant

I.E.M. GmbH

Stolberg, DE5 decisions2004–20160 recalls

FDA records 5 decisions for I.E.M. GmbH (Stolberg, DE) from 2004 to 2016: 5 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). Its devices cite 6 predicates, 3 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 I.E.M. GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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I.E.M. GmbH

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?