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Cochlear Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30090928183009092818Cochlear Ltd1N2026-01-011 University Ave Macquarie University New South Wales AU 2109

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1540821943583752P970051NUCLEUS 24 COCHLEAR IMPLANT SYSTEMMCM1998-06-25
1540822058052830P890027NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDRENMCM1990-06-27
1540821982404816P840024NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESIMCM1985-10-31
1540821832161304P130016NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEMPGQ2014-03-20
1540821834155520P000015NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEMMHE2000-10-20
1540821501299603K260902Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® SystemPFO2026-07-10
1540821657766126K231204Cochlear™ 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 AppPFO2023-08-18
1540821949737545K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitPFO2022-07-27
1540821616038863K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsPFO2019-11-15
1540821759978057K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsPFO2019-07-03
1540821419094588K153245Baha 5 Super Power Sound ProcessorLXB2016-03-02
1540821270243151
1540821433019673
1540821743040392

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PFO52026-07-10
MCM31998-06-25
LXB12016-03-02
PGQ12014-03-20
MHE12000-10-20