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Cochlear Limited - Brisbane

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96136463003045432Cochlear Limited - Brisbane1N2026-01-0112 Helen Street Newstead Queensland AU 4006

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1059181943583752P970051NUCLEUS 24 COCHLEAR IMPLANT SYSTEMMCM1998-06-25
1059182058052830P890027NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDRENMCM1990-06-27
1059181982404816P840024NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESIMCM1985-10-31
1059181832161304P130016NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEMPGQ2014-03-20
1059181834155520P000015NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEMMHE2000-10-20
1059181759978057K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsPFO2019-07-03
1059181419094588K153245Baha 5 Super Power Sound ProcessorLXB2016-03-02
1059181743040392

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MCM31998-06-25
PFO12019-07-03
LXB12016-03-02
PGQ12014-03-20
MHE12000-10-20