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Cochlear Americas Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
20
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0792-2020Class IICochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)December 18, 2018
Z-2155-2015Class IICochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile SiliconeJune 5, 2015
Z-1699-2014Class IICochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thicknessApril 9, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K240155Cochlear Osia SystemApril 18, 2024
K231604Instrument CaseAugust 24, 2023
K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear OsiaJuly 27, 2022
K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppSeptember 29, 2021
K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart AppFebruary 23, 2021
K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartNovember 15, 2019
K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, OsiaJuly 3, 2019
K182116BA310 Abutment, BIA310 Implant/AbutmentDecember 19, 2018
K171088Cochlear Baha SoundArcJune 7, 2017
K161123Baha 5 Power Sound ProcessorMay 20, 2016
K153245Baha 5 Super Power Sound ProcessorMarch 2, 2016
K150751Cordelle II Sound ProcessorJuly 22, 2015
K150555BA400 14mm AbutmentJuly 15, 2015
K142907Baha 5 Sound ProcessorMarch 25, 2015
K131240COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACTNovember 7, 2013
K132278COCHLEAR BAHA 4 SOUND PROCESSORSeptember 26, 2013
K121317COCHLEAR BAHA IMPLANT SYSTEMOctober 12, 2012
K110996BAHA 3 POWER SOUND PROCESSORMay 10, 2011
K100360BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENTJuly 13, 2010
K081606BAHA INTENSOAugust 28, 2008