Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009092818

FEI Number

3009092818

Entity Name

Cochlear Ltd

City/State/Country

Macquarie University New South Wales, AU

Establishment Address

1 University Ave, Macquarie University New South Wales 2109, AU

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

COCHLEAR AMERICAS (Owner Number: 9076254)

Owner / Operator Contact Address

10350 Park Meadows Drive, Lone Tree, CO 80124, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220922

PMA Number

N/A

All Registered Proprietary Names

N22 COCHLEAR IMPLANT SYS FOR PED Nucleus Auditory Brainstem Implant System 7M Magnet for CP1000 5(I) Coils Osia 2 System Nucleus Hybrid L24 Implant System Cochlear OsiaTM System Osia 2 System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2005-08-10
MHE	Implant, Auditory Brainstem	Unknown	Class 3	N/A	2005-08-10
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2005-08-10
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2022-02-17
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2019-11-19
PGQ	Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification	Unknown	Class 3	N/A	2014-04-16
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2019-09-16
SEM	Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring	Neurology	Class 2	882.1360	2025-07-30
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2022-07-29

Official Correspondent

No official correspondent registered.

US Agent Details

Laura Blair Business: Cochlear Americas Email: lblair@cochlear.com Phone: (800) 5235798

Related Public Records

Same Entity

COCHLEAR AMERICAS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002806740	COCHLEAR LTD.	LANE COVE New South Wales, AU
3013177549	Cochlear Malaysia Sdn Bhd	Kuala Lumpur Kuala Lumpur, MY
9616024	COCHLEAR BONE ANCHORED SOLUTIONS AB	Molnlycke Vastra Gotaland, SE
9613646	Cochlear Limited - Brisbane	Newstead Queensland, AU
3014579188	Cochlear Americas Warehouse	Centennial, CO, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2012	Cochlear Americas Inc.	3	Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.
Z-0044-05	Advanced Bionics	3	Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R (For Export Only) AB-5100H AB-5100H-01A

Similar Registrations

Registration Number	Establishment Name	Location
3009762645	Advanced Bionics LLC	Valencia, CA, US
9611813	CHRISTIAN DIENER GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3013177549	Cochlear Malaysia Sdn Bhd	Kuala Lumpur Kuala Lumpur, MY
9613646	Cochlear Limited - Brisbane	Newstead Queensland, AU
3014579188	Cochlear Americas Warehouse	Centennial, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009092818. Last updated year: 2026. Please use registration number 3009092818 when referencing this establishment in official correspondence.