FDA applicant

Med-El Elektromedizinische Geraete GmbH

Innsbruck, AT6 decisions2018–20200 recalls

FDA records 6 decisions for Med-El Elektromedizinische Geraete GmbH (Innsbruck, AT) from 2018 to 2020: 5 510(k) clearances and 1 De Novo grant. Most are in product codes PFO (Active Implantable Bone Conduction Hearing…) and LXB (Hearing Aid, Bone Conduction). Its devices cite 6 predicates, 4 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, ear, nose and throat panel, where it files most

How often FDA has decided Med-El Elektromedizinische Geraete GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2018high 2 (2018) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Med-El Elektromedizinische Geraete GmbH by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Med-El Elektromedizinische Geraete 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?