FDA applicant
MED-EL Elektromedizinische Geräte GmbH
FDA records 7 decisions for MED-EL Elektromedizinische Geräte GmbH (Innsbruck, AT) from 2000 to 2026: 6 510(k) clearances and 1 original PMA approval. Most are in product codes ETB (Prosthesis, Partial Ossicular Replacement) and ETA (Replacement, Ossicular Prosthesis, Total). Its devices cite 11 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Med-El Elektromedizinische Gerate GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided MED-EL Elektromedizinische Geräte GmbH’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like MED-EL Elektromedizinische Geräte GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report