COCHLEAR AMERICAS

FDA Device Registration & Listing · Lone Tree, CO, US · Registration 3005900820

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
3005900820
FEI Number
3005900820
Entity Name
COCHLEAR AMERICAS
City/State/Country
Lone Tree, CO, US
Establishment Address
10350 Park Meadows Drive, Lone Tree, CO 80124, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
COCHLEAR AMERICAS (Owner Number: 9076254)
Owner / Operator Contact Address
10350 Park Meadows Drive, Lone Tree, CO 80124, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Headband for Baha Osia 2 System Cochlear OsiaTM System Baha BA400 Abutment Cochlear Baha 7 System Baha Smart App Baha 7 Sound Processor and Accessories Cochlear SoundBand Baha Fitting Software 7 Baha Cordelle II Sound Processor Instrument Case (Phase 2) Baha 5 Cochlear Baha Remote Control Cochlear Wireless Mini Microphone Cochlear Wireless TV Streamer Cochlear Wireless Phone Clip Cochlear Baha Control App Mini Microphone Pro Mini Microphone 2 Nucleus Auditory Brainstem Implant System Baha 5 Power ENT Surgical Osscora Surgical Set Nucleus Hybrid L24 Implant System Medical Device Disinfectant Osia 2 System BAHA IMPLANT SYSTEM Ba400 14mm Abutment SoundArc BA310 Abutment, BIA310 Implant/Abutment Disposable Biopsy Punch N22 COCHLEAR IMPLANT SYS FOR PED 7M Magnet for CP1000 5(I) Coils Cochlear™ Baha® Fitting Software 6 Cochlear™ Baha® Baha Smart App Cochlear™ Baha® System Baha BIA300 Implants with Abutments NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Cochlear Surgical Instrument Upgrade Kit Nucleus SmartNav Cochlear Nucleus Kanso 3 Nexa Sound Processor and accessories Cochlear Nucleus 8 Nexa Sound Processor and Accessories Cochlear Nucleus Nexa cochlear implants Cochlear Nucleus Kanso 3 Sound Processor and accessories Nucleus Smart App Cochlear Objective Measures Cochlear surgical processors and accessories Custom Sound Pro Instrument Case Baha 6 Max Sound Processor Baha Smart App Baha Fitting Software 6

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2008-10-23
PFO Active Implantable Bone Conduction Hearing System Ear, Nose, Throat Class 2 874.3340 2019-11-19
PFO Active Implantable Bone Conduction Hearing System Ear, Nose, Throat Class 2 874.3340 2019-09-16
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2012-11-19
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2025-06-02
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2005-08-11
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2023-09-13
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-09-13
PFO Active Implantable Bone Conduction Hearing System Ear, Nose, Throat Class 2 874.3340 2023-09-13
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2015-04-23
OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription Ear, Nose, Throat Class 2 874.3305 2013-10-24
MHE Implant, Auditory Brainstem Unknown Class 3 N/A 2005-08-10
MCM Implant, Cochlear Unknown Class 3 N/A 2005-08-10
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2016-05-31
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2012-05-29
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 2003-03-07
PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown Class 3 N/A 2014-04-16
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2018-10-29
PFO Active Implantable Bone Conduction Hearing System Ear, Nose, Throat Class 2 874.3340 2022-07-29
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2005-08-11
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2015-07-23
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2017-06-23
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2019-04-04
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2006-09-19
MCM Implant, Cochlear Unknown Class 3 N/A 2005-08-10
MCM Implant, Cochlear Unknown Class 3 N/A 2022-02-17
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2022-01-17
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2010-10-06
MHE Implant, Auditory Brainstem Unknown Class 3 N/A 2005-08-10
MCM Implant, Cochlear Unknown Class 3 N/A 2005-08-10
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-09-13
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2021-02-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3009092818 Cochlear Ltd Macquarie University New South Wales, AU
9613646 Cochlear Limited - Brisbane Newstead Queensland, AU

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243425 Talladium España, SL Guided DAS Surgical Kit 2025-07-22
K213209 K1 Medical, LLC EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device 2021-12-28
K012105 Symmetry Medical, Inc. POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 2002-08-02
K243317 Infinitum Eta, Ltd. NUVENTUS NV.C™ Surgical Cassette and Tray 2025-02-11
K112536 Covidien SONICISION STERILIZATION TRAY 2012-04-19

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
Z-0025-2011 Medical Device Technologies, Inc. 1
Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recalling lot's for the product are as follows: Model Number: 763114100X Lot #'s: 92661WY5, 93211XXV, 00141YVE, 00541ZKX, 010920HL, 01522192, 92791X5I, 93271Y1W, 00201YYE, 00621ZQ3, 011320LH, 015221BD, 92791X7X, 93411Y9O, 00211Z0C, 00671ZRN, 011720Q, 015521CL, 92861XCT, 93421YBJ, 00251Z1T, 00761ZZP, 012420U0, 016221H2, 93001XLG, 93431YBI, 00351Z86, 0081201Y, 0138211F, 016721KJ, 93081XPC, 93571YJO, 00461ZE2, 0088206B, 0141215R, 93141XST, 00061YOV, 00541ZK0, 009620BO, 0146219M. Model Number: 763114160X Lot #'s 92661WY7, 00111YPZ, 00671ZRO, 013220Z7, 016221H7, 93131XLS, 00331Z61, 0110201Y, 014125Q, 00882065, 00391Z8Y, 013120YC, 015521CJ. Model Number: 763114200X Lot #'s 92661WY0, 00751ZYJ, 012420U1 Model Number: 763116100X Lot #'s 92791X80, 93491YG9, 00331Z6M, 0083203O, 012420U3, 01672KL, 92791X81, 93501YGA, 00351Z8D, 009620BL, 013120Y9, 92931XDD, 00121YRT, 00431ZE1, 009920D3, 015221AX, 93001XLN, 00131YUG, 00541ZKV, 011020IU, 015221BE, 93081XPH, 00541ZJY, 00601ZOT, 011320LG, 015521CK, 93291Y43, 00251Z1R, 0081201W, 012020QC, 016221H3. Model Number: 763116160X Lot #'s 92661WY3, 00882068, 00351Z8A, 00761ZZQ, 012020QB, 016721KK, 92791X89, 00912084, 00471ZG0, 010320FM, 012420TZ, 92861XD4, 01472193, 00541ZK1, 010920HK, 0141215U, 93001XLR, 00151YVC, 00601ZOR, 0110201V, 015521CM, 93291Y40, 00331Z6J, 00701ZUX, 011720OP, 016221HS Model Number: 763116200X Lot #'s 121KN Model Number: 763116200X Lot #'s 92671X09, 00471ZG1, 00882067, 010320FN, 00211Z09, 00601ZOP, 009920D0, 011020IT Model Number: 763118100X Lot #'s 92661WY8, 93491YG7, 00331Z6L, 00621ZQ2, 009920D2, 0138213F, 92791X7Z, 93491YG8, 00351Z88, 00701ZUW, 010320FL, 01472194, 92861XDS, 00061YOT, 00471ZG2, 00761ZZO, 0110201W, 016221H4, 93091XPL, 00131YUF, 00541ZJZ, 0083203P, 012020QE, 93211XXW, 00251Z1S, 00541ZKU, 009620BM, 012420TX. Model Number: 763118160X Lot #s 92661WY6, 93271Y1V, 00201YYD, 00471ZG3, 012420U2, 016221GZ, 92671WZJ, 93411Y9P, 00251Z1Q, 00671ZRK, 013120YB, 92671WZK, 93421YBK, 00331Z6N, 00701ZUY, 013220Z9, 92861XD0, 00061YOW, 00351Z8E, 00882069, 015221BB, 93001XLM, 00111YQO, 00431ZE3, 009920D4, 015521CO. Model Number: 763118200X Lot #s 92861XCD, 93571YJN, 00331Z6K, 00671ZRM, 011320LF, 01382134, 93001XL6, 0061YOU, 00351Z89,00701ZUZ, 011720OO, 0141215S, 93001XLJ, 00912082, 00391Z8Z, 009620BQ, 012020QA, 01472195, 93081XPJ, 00111YQM, 00471ZG5, 009920D5, 013120Y8, 016221H1, 93211XXX, 00131YUD, 00481ZG4, 010320FJ, 013220Z6, 93400Y9K, 00201YYC, 00621ZQ1, 010920HJ, 0137211I. Model Number: 763120100X Lot #s 93001XLV, 00351Z8B, 0088206A, 01472196, 00331Z60, 00601ZOS, 01202QF. Model Number: 763120160X Lot #s 92661WY1, 00882066, 00111YQP, 00351Z8C, 013120YD, 01472197, 92861XDG, 00912083, 00211Z08, 00621ZQ5, 013220Z8. Model Number: 763120200X Lot #s 00351Z85, 012020QG, 012420TW. Model Number: 763418200X Lot #s 92671WZV, 93291Y41, 00351Z87, 00601ZNH, 010320FK, 0141215T, 92671WZW, 00061YOX, 00431ZE0, 0083203N, 0110201S, 015221BC, 92861XDH, 00131YUE, 00491ZIO, 009620BN, 0011720ON, 015521CN, 93081XPR, 00141YVB, 00541ZKT, 009920D1, 0138213E, 016221H6. Model Number: 763418250X Lot #s 92751X60, 00671ZRL, Model Number: 763418250X Lot #s 92661WY4, 93271Y1N, 00141YVD, 00601ZOQ, 0110201X, 013220ZA, 92751X6P, 93291Y42, 00211Z0B, 00761ZZR, 012020QD, 0137211G, 92781X5G, 93631YJP, 00221Z13, 0081201X, 012420TY, 01382133, 92861XDN, 00912085, 00431ZDZ, 009620BP, 013120YA, 016221H0.

Similar Registrations

Registration Number Establishment Name Location
3014990990 SONITUS MEDICAL (SHANGHAI) CO., LTD. shanghai, CN
3034209804 YUH JAAN INDUSTRIAL CO., LTD. Taichung City, TW
3013177549 Cochlear Malaysia Sdn Bhd Kuala Lumpur Kuala Lumpur, MY
9613646 Cochlear Limited - Brisbane Newstead Queensland, AU
3007367732 Oticon Medical AB Askim Vastra Gotaland, SE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005900820. Last updated year: 2026. Please use registration number 3005900820 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.