Cochlear Americas Warehouse

FDA Device Registration & Listing · Centennial, CO, US · Registration 3014579188

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
3014579188
FEI Number
3014579188
Entity Name
Cochlear Americas Warehouse
City/State/Country
Centennial, CO, US
Establishment Address
7101 S. Fulton St., Suite E, Centennial, CO 80112, US
Establishment Type(s)
Repack or Relabel Medical Device,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
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Instrument Case Baha 5 Power Osia 2 System Baha BIA300 Implants with Abutments N22 COCHLEAR IMPLANT SYS FOR ADULTS Baha Cordelle II Sound Processor Baha BA400 Abutment Disposable Biopsy Punch Medical Device Disinfectant Cochlear OsiaTM System SoundArc 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 Cochlear Baha 7 System Baha Smart App Baha 7 Sound Processor and Accessories Cochlear SoundBand Baha Fitting Software 7 Headband for Baha Baha 6 Max Sound Processor Baha Smart App Baha Fitting Software 6 7M Magnet for CP1000 5(I) Coils Instrument Case (Phase 2) Baha Vistafix Baha 5 Baha Attract Nucleus Auditory Brainstem Implant System N22 COCHLEAR IMPLANT SYS FOR PED Osia 2 System 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 Nucleus Hybrid L24 Implant System BAHA IMPLANT SYSTEM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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 2016-05-31
PFO Active Implantable Bone Conduction Hearing System Ear, Nose, Throat Class 2 874.3340 2019-11-19
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2010-10-06
MCM Implant, Cochlear Unknown Class 3 N/A 2005-08-10
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 2012-11-19
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2006-09-19
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 2019-09-16
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2017-06-23
OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription Ear, Nose, Throat Class 2 874.3305 2013-10-24
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 2008-10-23
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2021-02-23
MCM Implant, Cochlear Unknown Class 3 N/A 2022-02-17
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
FZE Prosthesis, Nose, Internal General, Plastic Surgery Class 2 878.3680 2003-03-18
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2015-04-23
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2013-11-18
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 2005-08-10
PFO Active Implantable Bone Conduction Hearing System Ear, Nose, Throat Class 2 874.3340 2022-07-29
MHE Implant, Auditory Brainstem Unknown Class 3 N/A 2005-08-10
MCM Implant, Cochlear Unknown Class 3 N/A 2005-08-10
PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown Class 3 N/A 2014-04-16
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2005-08-11

Official Correspondent

Laura Blair

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014579188. Last updated year: 2026. Please use registration number 3014579188 when referencing this establishment in official correspondence.
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