Cochlear Malaysia Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Cochlear Malaysia Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3013177549
FEI Number3013177549
NameCochlear Malaysia Sdn Bhd
Owner & OperatorCOCHLEAR AMERICAS
Contact Address10350 Park Meadows Drive
Lone Tree CO 80124 US
Official Correspondent
  • Laura - Blair
  • x-303-2642752-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressUnit UG-1, Upper Ground Floor, Vertical Podium, The Vertical, Av Bangsar South, No 8 Jalan Kerinchi
Kuala Lumpur Wilayah Persekutuan Kuala L, 59200 MY
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Cochlear OsiaTM System2019-09-16
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Baha 5 Power2016-05-31
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Baha 5 SuperPower Sound Processor2016-03-02
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Ba400 14mm Abutment2015-07-23
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Baha 52015-04-23
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Nucleus Hybrid L24 Implant System2014-04-16
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Baha 4 Sound Processor2013-11-18
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Baha Attract2013-11-18
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Baha BA400 Abutment2012-11-19
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Cochlear Baha 3 Power Sound Processor (BP110)2011-12-12
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Baha BIA300 Implants with Abutments2010-10-06
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Cordelle II 65dB Sound Processor2010-10-06
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Baha BP100 Sound Processor2009-12-22
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Baha Intenso Sound Processor2008-10-23
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Baha Divino Sound Processor2008-10-23
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
BAHA HEADBAND2008-10-23
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Baha Cordelle II Sound Processor2005-08-11
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
BAHA IMPLANT SYSTEM2005-08-11
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM2005-08-10
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM2005-08-10
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Nucleus Auditory Brainstem Implant System2005-08-10
Cochlear Malaysia Sdn Bhd [COCHLEAR AMERICAS]
Nucleus Auditory Brainstem Implant System2005-08-10

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