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COCHLEAR BONE ANCHORED SOLUTIONS AB

Matched from indexed company URL: Cochlear Bone Anchored Solutions AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96160243003222064COCHLEAR BONE ANCHORED SOLUTIONS AB1N2026-01-01Konstruktionsvagen 14 Molnlycke Vastra Gotaland SE SE-435 33

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
09321502019613Baha - Widening drill 3 mm with countersink+1(800)523-5798customer@cochlear.com
09321502019620Baha - Widening drill 4 mm with countersink+1(800)523-5798customer@cochlear.com
09321502025157Baha - Baha ruler+1(800)523-5798customer@cochlear.com
09321502026505Baha - Conical guide drill 3+4 mm+1(800)523-5798customer@cochlear.com
09321502045018Bone Bed Indicator 14mm - P1578046+1(800)523-5798customer@cochlear.com
09321502045025Baha Indicator - P1582203+1(800)523-5798customer@cochlear.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
243341872844246K992872BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE IILXB1999-11-24
243341719180585K955713NOBELPHARMA BONE ANCHORED HEARING AIDLXB1996-08-09
243341493243306K945154BA-CPASFZE1995-01-13
243341688672643K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBandLXB2025-05-29
243341835900929K231604Instrument CaseKCT2023-08-24
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
243341502802806K223672Instrument Case P1340904KCT2023-03-21
243341949737545K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitPFO2022-07-27
243342059508989K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppLXB2021-09-29
243341480118991K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart AppLXB2021-02-23
243341616038863K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsPFO2019-11-15
243341759978057K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsPFO2019-07-03
243341144582357K182116BA310 Abutment, BIA310 Implant/AbutmentMAH2018-12-19
243341809521278K171088Cochlear Baha SoundArcLXB2017-06-07
243341458437286K161123Baha 5 Power Sound ProcessorLXB2016-05-20
243341419094588K153245Baha 5 Super Power Sound ProcessorLXB2016-03-02
243341438852972K150555BA400 14mm AbutmentMAH2015-07-15
243341053020436K142907Baha 5 Sound ProcessorLXB2015-03-25
243342006411856K132278COCHLEAR BAHA 4 SOUND PROCESSORLXB2013-09-26
243341628837463K131240COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACTLXB2013-11-07
243341249828683K121317COCHLEAR BAHA IMPLANT SYSTEMMAH2012-10-12
243341778568837K110996BAHA 3 POWER SOUND PROCESSORLXB2011-05-10
243341738330944K100360BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENTLXB2010-07-13
243341604529683K090720COCHLEAR BAHA BP100LXB2009-06-17
243341177317818K081606BAHA INTENSOLXB2008-08-28
243341034384694K080363BAHA CORDELLE IIMAH2008-04-10
243341782542877K042017BAHA DIVINOLXB2004-08-26
243341644407101K002913HEADBAND FOR BAHALXB2000-10-17
243341311891565
243341743040392
243341881216390

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LXB182025-05-29
PFO52023-08-18
MAH42018-12-19
KCT22023-08-24
FZE11995-01-13

GUDID#

200 records. Showing 1-40. Next