Advanced Bionics LLC

FDA Device Registration & Listing · Valencia, CA, US · Registration 3009762645

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009762645
FEI Number
1000220815
Entity Name
Advanced Bionics LLC
City/State/Country
Valencia, CA, US
Establishment Address
28515 Westinghouse Pl, Valencia, CA 91355, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Advanced Bionics LLC (Owner Number: 10023794)
Owner / Operator Contact Address
28515 Westinghouse Place, Valencia, CA 91355, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P960058

All Registered Proprietary Names

CLARION CII BIONIC EAR HIRESOLUTION BIONIC EAR SYSTEM Sky CI™ M90 Sound Processor Naida™ CI M90 Sound Processor Naida CI Q90 Naida CI Q70 Naida™ CI M30 Sound Processor Naida CI Q30

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MCM Implant, Cochlear Unknown Class 3 N/A 2007-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Advanced Bionics LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3030784382 Advanced Bionics North American Operations Center S.A. de C.V. Mexicali Baja California, MX

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
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.

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3013177549 Cochlear Malaysia Sdn Bhd Kuala Lumpur Kuala Lumpur, MY
3009092818 Cochlear Ltd Macquarie University New South Wales, AU
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 3009762645. Last updated year: 2026. Please use registration number 3009762645 when referencing this establishment in official correspondence.
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