510(k) Report

FDA applicant

Med-El Corp.

Innsbruck1 decision2001–20014 recalls

FDA records 1 decision for Med-El Corp. (Innsbruck) in 2001: 1 original PMA approval. All are in product code MCM (Implant, Cochlear). 4 recalls are 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 Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Med-El Corp. since 2007.

Recalls per year

1in 2024

2018: 32024: 1
2007high 3 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Med-El Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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