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 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 09321502043748 COCHLEAR LIMITED	Cochlear Magnetic battery removal tool P1316179	2023-07-28
GUDID 09321502041096 COCHLEAR LIMITED	Baha 5 Sound Processor Tamper-proof battery door 3 pcs P1129017	2023-07-28
GUDID 09321502036771 COCHLEAR LIMITED	SoftWear Pad P793406	2023-07-28
GUDID 09321502036764 COCHLEAR LIMITED	SoftWear Pad P793402	2023-07-28
GUDID 09321502033374 COCHLEAR LIMITED	Custom Sound Suite 4.4 Download P705392	2023-07-28
GUDID 09321502032247 COCHLEAR LIMITED	CUSTOM SOUND SUITE 4.2 CAM Z538301	2023-07-28
GUDID 09321502032230 COCHLEAR LIMITED	CUSTOM SOUND SUITE 4.2 Canada Z538300	2023-07-28
GUDID 09321502029612 COCHLEAR LIMITED	CUSTOM SOUND SUITE 4.1 SERVICE PACK 2 CAM Z532160	2023-07-28
GUDID 09321502029605 COCHLEAR LIMITED	CSS4.0 SERVICE PACK 1 - ENG - CAM Z475097	2023-07-28
GUDID 09321502029599 COCHLEAR LIMITED	CUSTOM SOUND SUITE 4.0 - CD VERSION - ENGLISH Z361240	2023-07-28
GUDID 09321502029568 COCHLEAR LIMITED	CUSTOM SOUND SUITE 3.2 SPANISH (US) Z301347	2023-07-28
GUDID 09321502029551 COCHLEAR LIMITED	CUSTOM SOUND SUITE 3.2 FRENCH (US) Z301344	2023-07-28
GUDID 09321502029537 COCHLEAR LIMITED	CUSTOM SOUND SUITE 3.0 DAL SR US ENGLISH Z252571	2023-07-28
GUDID 09321502029520 COCHLEAR LIMITED	CUSTOM SOUND SUITE 3.1 SPANISH (US) Z248945	2023-07-28
GUDID 09321502029513 COCHLEAR LIMITED	CUSTOM SOUND SUITE 3.0 SPANISH (US) Z239932	2023-07-28
GUDID 09321502029506 COCHLEAR LIMITED	CUSTOM SOUND SUITE 3.0 FRENCH (US) Z239930	2023-07-28
GUDID 09321502029483 COCHLEAR LIMITED	MAGNET INSERT,5M,BR,PKD Z60312	2023-07-28
GUDID 09321502029469 COCHLEAR LIMITED	CUSTOM SOUND SUITE 4.1 SOFTWARE - CAM Z494179	2023-07-28
GUDID 09321502029452 COCHLEAR LIMITED	CUSTOM SOUND SUITE 4.1 SP3 (US) - CD Z540369	2023-07-28
GUDID 09321502029445 COCHLEAR LIMITED	CUSTOM SOUND SUITE 4.1 SERVICE PACK 2 ROW-CANADA Z532157	2023-07-28
GUDID 09321502029438 COCHLEAR LIMITED	FREEDOM COIL MAGNET, BROWN, 0.5M S18142	2023-07-28
GUDID 09321502029421 COCHLEAR LIMITED	FREEDOM COIL MAGNET, BLACK, 4M S18147	2023-07-28
GUDID 09321502027557 COCHLEAR LIMITED	Cochlear Nucleus CR100 Series Remote Assistant USB Cable Z302512	2023-07-28
GUDID 09321502020480 COCHLEAR LIMITED	CUSTOM SOUND SUITE 3.2 ENGLISH (US) Z274923	2023-07-28
GUDID 09321502019873 COCHLEAR LIMITED	CUSTOM SOUND SUITE 3.1 ENGLISH (US) Z248940	2023-07-28
GUDID 09321502018913 COCHLEAR LIMITED	CUSTOM SOUND SUITE 2.0 SR2 US ENGLISH Z229456	2023-07-28
GUDID 09321502018906 COCHLEAR LIMITED	CUSTOM SOUND SUITE 3.0 US ENGLISH Z220129	2023-07-28
GUDID 09321502018418 COCHLEAR LIMITED	Nucleus CI500 Series Sterile Replacement Magnet Z179608	2023-07-28
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
GUDID 09321502023146 COCHLEAR LIMITED	Nucleus CP900 Series Magnet Z285912	2023-07-27
GUDID 09321502023139 COCHLEAR LIMITED	Nucleus CP900 Series Magnet Z285911	2023-07-27
GUDID 09321502023122 COCHLEAR LIMITED	Nucleus CP900 Series Magnet Z285910	2023-07-27
GUDID 09321502023108 COCHLEAR LIMITED	Nucleus CP900 Series Magnet Z285908	2023-07-27
GUDID 09321502023092 COCHLEAR LIMITED	Nucleus CP900 Series Magnet Z285907	2023-07-27
GUDID 09321502023085 COCHLEAR LIMITED	Nucleus CP900 Series Magnet Z285906	2023-07-27
GUDID 09321502023061 COCHLEAR LIMITED	Nucleus CP900 Series Magnet Z285904	2023-07-27
GUDID 09321502023047 COCHLEAR LIMITED	Nucleus CP900 Series Magnet Z285902	2023-07-27
GUDID 09321502022873 COCHLEAR LIMITED	Nucleus CP900 Series Magnet Z285885	2023-07-27
GUDID 09321502017473 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218525	2023-07-27
GUDID 09321502017466 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218524	2023-07-27
GUDID 09321502017459 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218523	2023-07-27
GUDID 09321502017442 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218522	2023-07-27
GUDID 09321502017435 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218521	2023-07-27
GUDID 09321502017428 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218520	2023-07-27
GUDID 09321502017404 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218518	2023-07-27
GUDID 09321502017381 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218516	2023-07-27
GUDID 09321502017374 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218515	2023-07-27
GUDID 09321502017350 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218513	2023-07-27
GUDID 09321502017343 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218512	2023-07-27
GUDID 09321502017336 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218511	2023-07-27
GUDID 09321502017329 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218510	2023-07-27
GUDID 09321502017312 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218509	2023-07-27
GUDID 09321502017305 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218508	2023-07-27
GUDID 09321502017299 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218507	2023-07-27
GUDID 09321502017282 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218506	2023-07-27
GUDID 09321502017275 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218505	2023-07-27
GUDID 09321502017251 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218503	2023-07-27
GUDID 09321502017244 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218501	2023-07-27
GUDID 09321502017237 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218500	2023-07-27
GUDID 09321502017220 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218498	2023-07-27
GUDID 09321502017213 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218497	2023-07-27
GUDID 09321502017206 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218496	2023-07-27
GUDID 09321502017190 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218495	2023-07-27
GUDID 09321502017183 COCHLEAR LIMITED	Nucleus CP800 Series Coil Magnet Z218494	2023-07-27
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