Cochlear
FDA 510(k) & PMA Approved Devices — 3 products
Total Devices3
Categories3
Latest FDA decision2025-05-29
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | LXB | 2025-05-29 | View |
| 510(k) | K231204 | Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App | PFO | 2023-08-18 | View |
| 510(k) | K223672 | Instrument Case P1340904 | KCT | 2023-03-21 | View |
No matching devices.
Related Clinical Trials
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