DEVICE CLASS
Class II
REGULATION
21 CFR 874.3302
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
K260452Zdeer Technology (Henan) Co., Ltd. · 510k2026-06-15
K261256Shenzhen Magnet Technology Co., Ltd. · 510k2026-06-11
K250215Cochlear · 510k2025-05-29
K243041Bhm-Tech Produktionsgesellschaft Mbh · 510k2025-04-25
Related on SPEQ
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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