Cochlear Americas
Cochlear Americas holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2026.
Top product codes for Cochlear Americas
Recent clearances by Cochlear Americas
- K260902 — Cochlear Osia® 3(I) Sound Processor +6 more
- K240155 — Cochlear Osia System
- K231604 — Instrument Case
- K220922 — Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
- K212136 — Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
- K202048 — Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
- K191921 — Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
- K190589 — Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
- K182116 — BA310 Abutment, BIA310 Implant/Abutment
- K171088 — Cochlear Baha SoundArc
- K161123 — Baha 5 Power Sound Processor
- K153245 — Baha 5 Super Power Sound Processor
- K150751 — Cordelle II Sound Processor
- K150555 — BA400 14mm Abutment
- K142907 — Baha 5 Sound Processor
- K131240 — COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
- K132278 — COCHLEAR BAHA 4 SOUND PROCESSOR
- K121317 — COCHLEAR BAHA IMPLANT SYSTEM
- K110996 — BAHA 3 POWER SOUND PROCESSOR
- K100360 — BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
- K081606 — BAHA INTENSO
Data sourced from openFDA. This site is unofficial and independent of the FDA.