FDA.reportPublic FDA data

Cochlear Limited - Brisbane

Matched from indexed company URL: COCHLEAR LIMITED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96136463003045432Cochlear Limited - Brisbane1N2026-01-0112 Helen Street Newstead Queensland AU 4006
96160243003222064COCHLEAR BONE ANCHORED SOLUTIONS AB1N2026-01-01Konstruktionsvagen 14 Molnlycke Vastra Gotaland SE SE-435 33
30059008203005900820COCHLEAR AMERICAS1N2026-01-0110350 Park Meadows Drive Lone Tree CO US 80124
30090928183009092818Cochlear Ltd1N2026-01-011 University Ave Macquarie University New South Wales AU 2109
30145791883014579188Cochlear Americas Warehouse1Y2026-01-017101 S. Fulton St. Suite E Centennial CO US 80112
30112100273011210027Cochlear Boulder LLC1N2020-04-255445 Airport Blvd Boulder CO US 80301

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
09321502006910Nucleus - Cochlear Nucleus Spacer for Intraoperative Testing+1(800)523-5798customer@cochlear.com
09321502014564Cochlear® Nucleus® CI512 cochlear Implant - with Contour Advance® electrode+1(800)523-5798customer@cochlear.com
09321502053082Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Straight electrode - Cochlear Implant+1(800)523-5798customer@cochlear.com
09321502053099Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Modiolar electrode - Cochlear Implant+1(800)523-5798customer@cochlear.com
09321502053105Cochlear™ Nucleus® Nexa™ cochlear implant with Slim 20 electrode - Cochlear Implant+1(800)523-5798customer@cochlear.com
09321502053662Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil - Hearing Implant Accessory+1(800)523-5798customer@cochlear.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
243301943583752P970051NUCLEUS 24 COCHLEAR IMPLANT SYSTEMMCM1998-06-25
1059181943583752P970051NUCLEUS 24 COCHLEAR IMPLANT SYSTEMMCM1998-06-25
1540821943583752P970051NUCLEUS 24 COCHLEAR IMPLANT SYSTEMMCM1998-06-25
2210541943583752P970051NUCLEUS 24 COCHLEAR IMPLANT SYSTEMMCM1998-06-25
243302058052830P890027NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDRENMCM1990-06-27
1059182058052830P890027NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDRENMCM1990-06-27
1540822058052830P890027NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDRENMCM1990-06-27
2210542058052830P890027NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDRENMCM1990-06-27
243301982404816P840024NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESIMCM1985-10-31
1059181982404816P840024NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESIMCM1985-10-31
1540821982404816P840024NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESIMCM1985-10-31
2210541982404816P840024NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESIMCM1985-10-31
243301832161304P130016NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEMPGQ2014-03-20
1059181832161304P130016NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEMPGQ2014-03-20
1540821832161304P130016NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEMPGQ2014-03-20
2210541832161304P130016NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEMPGQ2014-03-20
243301834155520P000015NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEMMHE2000-10-20
1059181834155520P000015NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEMMHE2000-10-20
1540821834155520P000015NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEMMHE2000-10-20
2210541834155520P000015NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEMMHE2000-10-20
243301872844246K992872BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE IILXB1999-11-24
243341872844246K992872BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE IILXB1999-11-24
2210541872844246K992872BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE IILXB1999-11-24
243301719180585K955713NOBELPHARMA BONE ANCHORED HEARING AIDLXB1996-08-09
243341719180585K955713NOBELPHARMA BONE ANCHORED HEARING AIDLXB1996-08-09
2210541719180585K955713NOBELPHARMA BONE ANCHORED HEARING AIDLXB1996-08-09
243301493243306K945154BA-CPASFZE1995-01-13
243341493243306K945154BA-CPASFZE1995-01-13
2210541493243306K945154BA-CPASFZE1995-01-13
243301688672643K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBandLXB2025-05-29
243341688672643K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBandLXB2025-05-29
2210541688672643K250215Baha 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
243341835900929K231604Instrument CaseKCT2023-08-24
2210541835900929K231604Instrument 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
243341657766126K231204Cochlear™ 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
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
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
243301502802806K223672Instrument Case P1340904KCT2023-03-21
243341502802806K223672Instrument Case P1340904KCT2023-03-21
2210541502802806K223672Instrument 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
243341949737545K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitPFO2022-07-27
1540821949737545K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitPFO2022-07-27
2210541949737545K220922Cochlear 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
243342059508989K212136Cochlear 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
243341480118991K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart AppLXB2021-02-23
2210541480118991K202048Cochlear 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
243341616038863K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsPFO2019-11-15
1540821616038863K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsPFO2019-11-15
2210541616038863K191921Cochlear 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
243341759978057K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsPFO2019-07-03
1059181759978057K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsPFO2019-07-03
1540821759978057K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsPFO2019-07-03
2210541759978057K190589Cochlear 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
243341144582357K182116BA310 Abutment, BIA310 Implant/AbutmentMAH2018-12-19
2210541144582357K182116BA310 Abutment, BIA310 Implant/AbutmentMAH2018-12-19
243301809521278K171088Cochlear Baha SoundArcLXB2017-06-07
243341809521278K171088Cochlear Baha SoundArcLXB2017-06-07
2210541809521278K171088Cochlear Baha SoundArcLXB2017-06-07
243301458437286K161123Baha 5 Power Sound ProcessorLXB2016-05-20
243341458437286K161123Baha 5 Power Sound ProcessorLXB2016-05-20
2210541458437286K161123Baha 5 Power Sound ProcessorLXB2016-05-20
243301419094588K153245Baha 5 Super Power Sound ProcessorLXB2016-03-02
243341419094588K153245Baha 5 Super Power Sound ProcessorLXB2016-03-02
1059181419094588K153245Baha 5 Super Power Sound ProcessorLXB2016-03-02
1540821419094588K153245Baha 5 Super Power Sound ProcessorLXB2016-03-02
2210541419094588K153245Baha 5 Super Power Sound ProcessorLXB2016-03-02
243301438852972K150555BA400 14mm AbutmentMAH2015-07-15
243341438852972K150555BA400 14mm AbutmentMAH2015-07-15
2210541438852972K150555BA400 14mm AbutmentMAH2015-07-15
243301053020436K142907Baha 5 Sound ProcessorLXB2015-03-25
243341053020436K142907Baha 5 Sound ProcessorLXB2015-03-25
2210541053020436K142907Baha 5 Sound ProcessorLXB2015-03-25
243302006411856K132278COCHLEAR BAHA 4 SOUND PROCESSORLXB2013-09-26
243342006411856K132278COCHLEAR BAHA 4 SOUND PROCESSORLXB2013-09-26
243301628837463K131240COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACTLXB2013-11-07
243341628837463K131240COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACTLXB2013-11-07
2210541628837463K131240COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACTLXB2013-11-07
243301249828683K121317COCHLEAR BAHA IMPLANT SYSTEMMAH2012-10-12
243341249828683K121317COCHLEAR BAHA IMPLANT SYSTEMMAH2012-10-12
2210541249828683K121317COCHLEAR BAHA IMPLANT SYSTEMMAH2012-10-12
243301778568837K110996BAHA 3 POWER SOUND PROCESSORLXB2011-05-10
243341778568837K110996BAHA 3 POWER SOUND PROCESSORLXB2011-05-10
243301738330944K100360BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENTLXB2010-07-13
243341738330944K100360BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENTLXB2010-07-13
2210541738330944K100360BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENTLXB2010-07-13
243301604529683K090720COCHLEAR BAHA BP100LXB2009-06-17
243341604529683K090720COCHLEAR BAHA BP100LXB2009-06-17
2210541604529683K090720COCHLEAR BAHA BP100LXB2009-06-17
243301177317818K081606BAHA INTENSOLXB2008-08-28
243341177317818K081606BAHA INTENSOLXB2008-08-28
2210541177317818K081606BAHA INTENSOLXB2008-08-28
243301034384694K080363BAHA CORDELLE IIMAH2008-04-10
243341034384694K080363BAHA CORDELLE IIMAH2008-04-10
243301782542877K042017BAHA DIVINOLXB2004-08-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LXB602025-05-29
PFO202023-08-18
MCM151998-06-25
MAH132018-12-19
KCT62023-08-24
PGQ52014-03-20
MHE52000-10-20
FZE41995-01-13

PMA#

Nucleus 24 Cochlear Implant System

2022-12-15

Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS216 Date Received11/21/2022 Decision Date12/15/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Su...

Nucleus 24 Cochlear Implant System

2022-12-06

Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS214 Date Received09/07/2022 Decision Date12/06/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason...

Nucleus Hybrid L24 Cochlear Implant System

2022-12-06

Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS051 Date Received09/07/2022 Decision Date12/06/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason...

Nucleus® 24 Cochlear Implant System

2022-12-06

Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS215 Date Received11/14/2022 Decision Date12/06/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Pro...

Nucleus 24 Auditory Brainstem Implant System

2022-12-06

Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP000015 Supplement NumberS048 Date Received09/07/2022 Decision Date12/06/2022 Product Code MHE  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason...

Nucleus Cochlear Implant Systems

2022-10-31

Cochlear Americas13059 E Peakview Avecentennial, CO 80111 PMA NumberP890027 Supplement NumberS062 Date Received04/26/2022 Decision Date10/31/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track Supplement Reason Ch...

Nucleus Auditory Brainstem Implant

2022-10-31

Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP000015 Supplement NumberS047 Date Received04/26/2022 Decision Date10/31/2022 Product Code MHE  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track Supplement Rea...

Nucleus Cochlear Implant Systems

2022-10-31

Cochlear Americas400 Inverness Parkway,suite 400englewood, CO 80112 PMA NumberP840024 Supplement NumberS094 Date Received04/26/2022 Decision Date10/31/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track Supplement...

Nucleus® 24 Cochlear Implant System

2022-08-09

Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS213 Date Received07/11/2022 Decision Date08/09/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Pro...

Nucleus Hybrid L24 Implant System

2022-06-16

Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS049 Date Received05/02/2022 Decision Date06/16/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Su...

Nucleus 24 Cochlear Implant System

2022-03-11

Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS210 Date Received02/08/2022 Decision Date03/11/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Su...

Nucleus® Hybrid™ L24 Cochlear Implant System

2022-03-03

Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS047 Date Received02/01/2022 Decision Date03/03/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Pro...

Nucleus® 24 Cochlear Implant System

2022-03-03

Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS209 Date Received02/01/2022 Decision Date03/03/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Pro...

200 records. Showing 1-40. Next

PMN#

GUDID#

200 records. Showing 1-40. Next