Cochlear L T D

FDA Filings

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

AUSTRALIA

AUSTRALIAN STOCK EXCHANGE

COH

DUNS 750551194

FDA Registration(s)

• Registration Number: 3002806740
• FEI Number: 3002806740
• Name: COCHLEAR LTD.
• Owner & Operator: COCHLEAR AMERICAS
• Contact Address: 10350 Park Meadows Drive ; Lone Tree CO 80124 US
• Official Correspondent:
  • Laura - Blair
  • x-303-2642752-x
• US Agent:
  • Laura Blair
  • Cochlear Americas
  • 303 2642752
  • 303 5246825
  • lblair@cochlear.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 14 MARS ROAD ; LANE COVE New South Wales, 2066 AU
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 09321502081665 COCHLEAR LIMITED	Cochlear™ Kanso® 3 Microphone Cover P1967088	2025-07-15
GUDID 09321502081658 COCHLEAR LIMITED	Cochlear™ Kanso® 3 Microphone Cover P1967087	2025-07-15
GUDID 09321502081641 COCHLEAR LIMITED	Cochlear™ Kanso® 3 Microphone Cover P1967086	2025-07-15
GUDID 09321502081634 COCHLEAR LIMITED	Cochlear™ Kanso® 3 Microphone Cover P1967085	2025-07-15
GUDID 09321502081627 COCHLEAR LIMITED	Cochlear™ Kanso® 3 Microphone Cover P1967084	2025-07-15
GUDID 09321502073110 COCHLEAR LIMITED	Cochlear™ CP1110S Surgical Coil, 2m P1998830	2025-07-15
GUDID 09321502072359 COCHLEAR LIMITED	Custom Sound Pro P1947519	2025-07-15
GUDID 09321502070416 COCHLEAR LIMITED	Cochlear™ Objective Measures P1986795	2025-07-15
GUDID 09321502069847 COCHLEAR LIMITED	Cochlear™ Nucleus® Nexa™ cochlear implant with Contour Advance® electrode P1979576	2025-07-15
GUDID 09321502069830 COCHLEAR LIMITED	Cochlear™ Nucleus® Kanso® 3 Nexa™ Sound Processor P1884802	2025-07-15
GUDID 09321502069823 COCHLEAR LIMITED	Cochlear™ Nucleus® Kanso® 3 Nexa™ Sound Processor P1884801	2025-07-15
GUDID 09321502069816 COCHLEAR LIMITED	Cochlear™ Nucleus® Kanso® 3 Nexa™ Sound Processor P1884800	2025-07-15
GUDID 09321502069809 COCHLEAR LIMITED	Cochlear™ Nucleus® Kanso® 3 Nexa™ Sound Processor P1884799	2025-07-15
GUDID 09321502069793 COCHLEAR LIMITED	Cochlear™ Nucleus® Kanso® 3 Nexa™ Sound Processor P1884798	2025-07-15
GUDID 09321502069786 COCHLEAR LIMITED	Cochlear™ Nucleus® Kanso® 3 Sound Processor P1884777	2025-07-15
GUDID 09321502069779 COCHLEAR LIMITED	Cochlear™ Nucleus® Kanso® 3 Sound Processor P1884776	2025-07-15
GUDID 09321502069762 COCHLEAR LIMITED	Cochlear™ Nucleus® Kanso® 3 Sound Processor P1884775	2025-07-15
GUDID 09321502069755 COCHLEAR LIMITED	Cochlear™ Nucleus® Kanso® 3 Sound Processor P1884774	2025-07-15
GUDID 09321502069748 COCHLEAR LIMITED	Cochlear™ Nucleus® Kanso® 3 Sound Processor P1884773	2025-07-15
GUDID 09321502065252 COCHLEAR LIMITED	Cochlear™ Surgical Processing Unit P1840761	2025-07-15
GUDID 09321502062107 COCHLEAR LIMITED	Cochlear™ Power Compact Battery Module P1757671	2025-07-15
GUDID 09321502062091 COCHLEAR LIMITED	Cochlear™ Power Compact Battery Module P1757702	2025-07-15
GUDID 09321502062084 COCHLEAR LIMITED	Cochlear™ Power Compact Battery Module P1757677	2025-07-15
GUDID 09321502062077 COCHLEAR LIMITED	Cochlear™ Power Compact Battery Module P1757701	2025-07-15
GUDID 09321502062060 COCHLEAR LIMITED	Cochlear™ Power Compact Battery Module P1757675	2025-07-15
GUDID 09321502062053 COCHLEAR LIMITED	Cochlear™ Power Compact Battery Module P1757676	2025-07-15
GUDID 09321502054348 COCHLEAR LIMITED	Cochlear™ CP1110S Surgical Coil P1749715	2025-07-15
GUDID 09321502054317 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Aqua+ Coil P1749712	2025-07-15
GUDID 09321502054287 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Aqua+ Coil P1749709	2025-07-15
GUDID 09321502054195 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749700	2025-07-15
GUDID 09321502054188 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749699	2025-07-15
GUDID 09321502054171 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749698	2025-07-15
GUDID 09321502054164 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749697	2025-07-15
GUDID 09321502054157 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749696	2025-07-15
GUDID 09321502054140 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749695	2025-07-15
GUDID 09321502054010 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749682	2025-07-15
GUDID 09321502054003 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749681	2025-07-15
GUDID 09321502053990 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749680	2025-07-15
GUDID 09321502053983 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749679	2025-07-15
GUDID 09321502053976 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749678	2025-07-15
GUDID 09321502053969 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749677	2025-07-15
GUDID 09321502053839 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749664	2025-07-15
GUDID 09321502053822 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749663	2025-07-15
GUDID 09321502053815 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749662	2025-07-15
GUDID 09321502053808 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749661	2025-07-15
GUDID 09321502053792 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749660	2025-07-15
GUDID 09321502053785 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749659	2025-07-15
GUDID 09321502053716 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749652	2025-07-15
GUDID 09321502053709 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749651	2025-07-15
GUDID 09321502053693 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749650	2025-07-15
GUDID 09321502053686 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749649	2025-07-15
GUDID 09321502053679 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749648	2025-07-15
GUDID 09321502053662 COCHLEAR LIMITED	Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil P1749647	2025-07-15
GUDID 09321502053105 COCHLEAR LIMITED	Cochlear™ Nucleus® Nexa™ cochlear implant with Slim 20 electrode P1549674	2025-07-15
GUDID 09321502053099 COCHLEAR LIMITED	Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Modiolar electrode P1434929	2025-07-15
GUDID 09321502053082 COCHLEAR LIMITED	Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Straight electrode Z334204	2025-07-15
GUDID 09321502046152 COCHLEAR LIMITED	Cochlear P1170466	2025-03-07
GUDID 09321502024655 COCHLEAR LIMITED	Nucleus Z327613	2025-03-07
GUDID 09321502018395 COCHLEAR LIMITED	Nucleus Z146624	2025-03-07
GUDID 09321502013369 COCHLEAR LIMITED	Nucleus Z179609	2025-03-07
GUDID 09321502002790 COCHLEAR LIMITED	Nucleus Z60006	2025-03-07
GUDID 09321502002776 COCHLEAR LIMITED	Nucleus Z50100	2025-03-07
GUDID 09321502026895 COCHLEAR LIMITED	Nucleus Z463269	2025-02-18
GUDID 09321502014557 COCHLEAR LIMITED	Cochlear Surgical Instrument Upgrade Kit Z145225	2024-11-15
GUDID 09321502009218 COCHLEAR LIMITED	Nucleus Z60770	2023-11-21
GUDID 09321502063999 COCHLEAR LIMITED	Cochlear Research Platform ECochG Software P1877856	2023-11-03
GUDID 09321502046503 COCHLEAR LIMITED	Cochlear P1593077	2023-11-03
GUDID 09321502046145 COCHLEAR LIMITED	Cochlear P1340354	2023-11-03
GUDID 09321502046138 COCHLEAR LIMITED	Cochlear P1340352	2023-11-03
GUDID 09321502044905 COCHLEAR LIMITED	Cochlear P1348428	2023-11-03
GUDID 09321502044899 COCHLEAR LIMITED	Cochlear P1341442	2023-11-03
GUDID 09321502043236 COCHLEAR LIMITED	Nucleus P1285539	2023-11-03
GUDID 09321502043212 COCHLEAR LIMITED	Nucleus P1256009	2023-11-03
GUDID 09321502043205 COCHLEAR LIMITED	Nucleus P1257243	2023-11-03
GUDID 09321502036788 COCHLEAR LIMITED	Nucleus P832154	2023-11-03
GUDID 09321502070997 COCHLEAR LIMITED	Osia 2(I) SP Magnet (I) Tool P1900829	2023-09-25
GUDID 09321502070980 COCHLEAR LIMITED	Osia 2(I) SP Magnet strength 4(I) P1900826	2023-09-25
GUDID 09321502070973 COCHLEAR LIMITED	Osia 2(I) SP Magnet strength 3(I) P1900825	2023-09-25
GUDID 09321502070966 COCHLEAR LIMITED	Osia 2 (I) SP Magnet strength 2(I) P1900824	2023-09-25
GUDID 09321502070959 COCHLEAR LIMITED	Osia 2(I) SP Magnet strength 1(I) P1900472	2023-09-25
GUDID 09321502070683 COCHLEAR LIMITED	Cochlear™ Magnet Cassette P1773917	2023-09-25
GUDID 09321502070676 COCHLEAR LIMITED	Osia OSI300 Implant P1772248	2023-09-25
GUDID 09321502070409 COCHLEAR LIMITED	Osia 2(I) Sound Processor kit P1900830	2023-09-25
GUDID 09321502016568 COCHLEAR LIMITED	Cochlear Baha Telecoil 91181	2023-07-28
GUDID 09321502016551 COCHLEAR LIMITED	Cochlear Baha Audio adapter Short Cable 91180	2023-07-28
GUDID 09321502015295 COCHLEAR LIMITED	USB CABLE Z60766	2023-07-28
GUDID 09321502014540 COCHLEAR LIMITED	MAGNET INSERT,5M,BG,PKD Z60311	2023-07-28
GUDID 09321502012041 COCHLEAR LIMITED	MAGNET INSERT, 6M , BLACK Z61150	2023-07-28
GUDID 09321502012034 COCHLEAR LIMITED	MAGNET INSERT, 6M, BROWN Z61149	2023-07-28
GUDID 09321502012027 COCHLEAR LIMITED	MAGNET INSERT, 6M, BEIGE Z61148	2023-07-28
GUDID 09321502011921 COCHLEAR LIMITED	CUSTOM SOUND SUITE 2.0 SR1 FRENCH Z194952	2023-07-28
GUDID 09321502011624 COCHLEAR LIMITED	CUSTOM SND SUITE 1.3 SERV RELEASE 1 Z61155	2023-07-28
GUDID 09321502011556 COCHLEAR LIMITED	MAGNET INSERT,5M,BK,PKD Z60313	2023-07-28
GUDID 09321502008921 COCHLEAR LIMITED	MAGNET INSERT,5M, GREY Z60421	2023-07-28
GUDID 09321502008839 COCHLEAR LIMITED	MAGNET INSERT,4M, GREY Z60420	2023-07-28
GUDID 09321502008600 COCHLEAR LIMITED	MAGNET INSERT,2M, GREY Z60418	2023-07-28
GUDID 09321502008594 COCHLEAR LIMITED	MAGNET INSERT,1M, GREY Z60417	2023-07-28
GUDID 09321502008587 COCHLEAR LIMITED	MAGNET INSERT,1/2M, GREY Z60416	2023-07-28
GUDID 09321502002783 COCHLEAR LIMITED	CI24RE Series Sterile Replacement Magnet Z50101	2023-07-28
GUDID 09321502002448 COCHLEAR LIMITED	CLINICAL PROGRAMMING SYSTEM Z43102	2023-07-28
PMN P130016 | PGQ COCHLEAR LTD. [COCHLEAR AMERICAS]	Nucleus Hybrid L24 Implant System	2014-04-16
OUG COCHLEAR LTD. [COCHLEAR AMERICAS]	Medical Device Data System	2014-01-06
LRC COCHLEAR LTD. [COCHLEAR AMERICAS]	ENT Surgical	2012-05-29
PMN P970051 | MHE COCHLEAR LTD. [COCHLEAR AMERICAS]	NUCLEUS 24 COCHLEAR IMPLANT SYSTEM	2005-08-10
PMN P970051 | MCM COCHLEAR LTD. [COCHLEAR AMERICAS]	NUCLEUS 24 COCHLEAR IMPLANT SYSTEM	2005-08-10
PMN P890027 | MCM COCHLEAR LTD. [COCHLEAR AMERICAS]	N22 COCHLEAR IMPLANT SYS FOR PED	2005-08-10
PMN P840024 | MCM COCHLEAR LTD. [COCHLEAR AMERICAS]	N22 COCHLEAR IMPLANT SYS FOR ADULTS	2005-08-10
PMN P000015 | MHE COCHLEAR LTD. [COCHLEAR AMERICAS]	Nucleus Auditory Brainstem Implant System	2005-08-10
PMN P000015 | MCM COCHLEAR LTD. [COCHLEAR AMERICAS]	Nucleus Auditory Brainstem Implant System	2005-08-10

Similar & Related FDA Registered Companies

• COCHLEAR LABORATORIES, LTD.
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS216 Date Received11/21/2022 Decision Date12/15/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP000015 Supplement NumberS048 Date Received09/07/2022 Decision Date12/06/2022 Product Code MHE  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS215 Date Received11/14/2022 Decision Date12/06/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS214 Date Received09/07/2022 Decision Date12/06/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS051 Date Received09/07/2022 Decision Date12/06/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Cochlear Americas13059 E Peakview Avecentennial, CO 80111 PMA NumberP890027 Supplement NumberS062 Date Received04/26/2022 Decision Date10/31/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Cochlear Americas400 Inverness Parkway,suite 400englewood, CO 80112 PMA NumberP840024 Supplement NumberS094 Date Received04/26/2022 Decision Date10/31/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP000015 Supplement NumberS047 Date Received04/26/2022 Decision Date10/31/2022 Product Code MHE  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS213 Date Received07/11/2022 Decision Date08/09/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS049 Date Received05/02/2022 Decision Date06/16/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS210 Date Received02/08/2022 Decision Date03/11/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS047 Date Received02/01/2022 Decision Date03/03/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS209 Date Received02/01/2022 Decision Date03/03/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS050 Date Received07/11/2022 Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	Z0NY0	COCHLEAR LIMITED
CAGE Code	Z0NY0	COCHLEAR LIMITED
S.A.M. Registration	Z0NY0 [750551194]	COCHLEAR LIMITED
SEC	0001453930	Cochlear Ltd / ADR

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020061221456	Yantian,China (Mainland) -> Long Beach, California	EVE BOX	125 CTN
2020060524754	Yantian,China (Mainland) -> Long Beach, California	EVE BOX	125 CTN
2020060442623	Yantian,China (Mainland) -> Long Beach, California	EVE BOX	125 CTN
2020060352393	Yantian,China (Mainland) -> Long Beach, California	EVE BOX	125 CTN
2020041716947	Vung Tau,Vietnam -> Los Angeles, California	RECIPIENT BACKPACK	528 CTN
2020041343099	Vung Tau,Vietnam -> Los Angeles, California	RECIPIENT BACKPACK	528 CTN
2020012937750	Shilong,China (Taiwan) -> Los Angeles, California	EVERYDAY CASE	125 CTN
2019081947385	Yantian,China (Mainland) -> Los Angeles, California	NEW RECIPIENT BACKPACK	660 CTN