FDA.reportPublic FDA data

Cochlear Americas Warehouse

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30145791883014579188Cochlear Americas Warehouse1Y2026-01-017101 S. Fulton St. Suite E Centennial CO US 80112

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2210541943583752P970051NUCLEUS 24 COCHLEAR IMPLANT SYSTEMMCM1998-06-25
2210542058052830P890027NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDRENMCM1990-06-27
2210541982404816P840024NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESIMCM1985-10-31
2210541832161304P130016NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEMPGQ2014-03-20
2210541834155520P000015NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEMMHE2000-10-20
2210541872844246K992872BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE IILXB1999-11-24
2210541719180585K955713NOBELPHARMA BONE ANCHORED HEARING AIDLXB1996-08-09
2210541493243306K945154BA-CPASFZE1995-01-13
2210541688672643K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBandLXB2025-05-29
2210541835900929K231604Instrument CaseKCT2023-08-24
2210541657766126K231204Cochlear™ 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
2210541502802806K223672Instrument Case P1340904KCT2023-03-21
2210541949737545K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitPFO2022-07-27
2210541480118991K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart AppLXB2021-02-23
2210541616038863K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsPFO2019-11-15
2210541759978057K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsPFO2019-07-03
2210541144582357K182116BA310 Abutment, BIA310 Implant/AbutmentMAH2018-12-19
2210541809521278K171088Cochlear Baha SoundArcLXB2017-06-07
2210541458437286K161123Baha 5 Power Sound ProcessorLXB2016-05-20
2210541419094588K153245Baha 5 Super Power Sound ProcessorLXB2016-03-02
2210541438852972K150555BA400 14mm AbutmentMAH2015-07-15
2210541053020436K142907Baha 5 Sound ProcessorLXB2015-03-25
2210541628837463K131240COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACTLXB2013-11-07
2210541249828683K121317COCHLEAR BAHA IMPLANT SYSTEMMAH2012-10-12
2210541738330944K100360BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENTLXB2010-07-13
2210541604529683K090720COCHLEAR BAHA BP100LXB2009-06-17
2210541177317818K081606BAHA INTENSOLXB2008-08-28
2210541782542877K042017BAHA DIVINOLXB2004-08-26
2210541644407101K002913HEADBAND FOR BAHALXB2000-10-17
2210541311891565
2210541433019673
2210541613017155
2210541721860873
2210541743040392
2210541881216390

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LXB152025-05-29
PFO42023-08-18
MAH32018-12-19
MCM31998-06-25
KCT22023-08-24
PGQ12014-03-20
MHE12000-10-20
FZE11995-01-13