FDA applicant

G.Tec Medical Engineering GmbH

Schiedlberg, AT6 decisions2006–20200 recalls

FDA records 6 decisions for G.Tec Medical Engineering GmbH (Schiedlberg, AT) from 2006 to 2020: 6 510(k) clearances. Most are in product codes GWL (Amplifier, Physiological Signal) and OLU (Normalizing Quantitative Electroencephalograph…). Its devices cite 9 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, neurology panel, where it files most

How often FDA has decided G.Tec Medical Engineering GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2007high 2 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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G.Tec Medical Engineering 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?