FDA.reportPublic FDA data

COCHLEAR AMERICAS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30059008203005900820COCHLEAR AMERICAS1N2026-01-0110350 Park Meadows Drive Lone Tree CO US 80124

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
243301943583752P970051NUCLEUS 24 COCHLEAR IMPLANT SYSTEMMCM1998-06-25
243302058052830P890027NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDRENMCM1990-06-27
243301982404816P840024NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESIMCM1985-10-31
243301832161304P130016NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEMPGQ2014-03-20
243301834155520P000015NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEMMHE2000-10-20
243301872844246K992872BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE IILXB1999-11-24
243301719180585K955713NOBELPHARMA BONE ANCHORED HEARING AIDLXB1996-08-09
243301493243306K945154BA-CPASFZE1995-01-13
243301501299603K260902Cochlear™ 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
243301688672643K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBandLXB2025-05-29
243301835900929K231604Instrument CaseKCT2023-08-24
243301657766126K231204Cochlear™ 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
243301502802806K223672Instrument Case P1340904KCT2023-03-21
243301949737545K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitPFO2022-07-27
243302059508989K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppLXB2021-09-29
243301480118991K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart AppLXB2021-02-23
243301616038863K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsPFO2019-11-15
243301759978057K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsPFO2019-07-03
243301144582357K182116BA310 Abutment, BIA310 Implant/AbutmentMAH2018-12-19
243301809521278K171088Cochlear Baha SoundArcLXB2017-06-07
243301458437286K161123Baha 5 Power Sound ProcessorLXB2016-05-20
243301419094588K153245Baha 5 Super Power Sound ProcessorLXB2016-03-02
243301438852972K150555BA400 14mm AbutmentMAH2015-07-15
243301053020436K142907Baha 5 Sound ProcessorLXB2015-03-25
243302006411856K132278COCHLEAR BAHA 4 SOUND PROCESSORLXB2013-09-26
243301628837463K131240COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACTLXB2013-11-07
243301249828683K121317COCHLEAR BAHA IMPLANT SYSTEMMAH2012-10-12
243301778568837K110996BAHA 3 POWER SOUND PROCESSORLXB2011-05-10
243301738330944K100360BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENTLXB2010-07-13
243301604529683K090720COCHLEAR BAHA BP100LXB2009-06-17
243301177317818K081606BAHA INTENSOLXB2008-08-28
243301034384694K080363BAHA CORDELLE IIMAH2008-04-10
243301782542877K042017BAHA DIVINOLXB2004-08-26
243301644407101K002913HEADBAND FOR BAHALXB2000-10-17
243301113694923
243301311891565
243301721860873
243301743040392
243301881216390
243301433019673
243301613017155

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LXB252025-05-29
PFO72026-07-10
MAH62018-12-19
MCM61998-06-25
KCT22023-08-24
PGQ22014-03-20
MHE22000-10-20
FZE21995-01-13

PMA#

200 records. Showing 1-40. Next

PMN#