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FDA PRODUCT CODE · CLASS II

ETB — Prosthesis, Partial Ossicular Replacement

DEVICE CLASS
Class II
REGULATION
21 CFR 874.3450
MEDICAL SPECIALTY
Ear, Nose, Throat
REVIEW PANEL
EN
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K260718MED-EL Elektromedizinische Geräte GmbH · 510k2026-04-03
K260720MED-EL Elektromedizinische Geräte GmbH · 510k2026-04-03
K241142MED-EL Elektromedizinische Geräte GmbH · 510k2025-01-17
K241261MED-EL Elektromedizinische Geräte GmbH · 510k2025-01-17

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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