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COCHLEAR AMERICAS

USA · Lone Tree
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
14listed device types
Class I 5Class II 6Class III 3
plus 68 registration records and 21 510(k), 501 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States68 registration records, 21 510(k), 501 PMA, 8 excluded
Brazil0 confirmed, 5 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: COCHLEAR AMERICAS · Cochlear Americas Warehouse
Same-named companies — This database also contains companies with near-identical names: Cochlear Americas Warehouse. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Lone Tree

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12008
12010
12011
12012
22013
32015
22016
12017
12018
22019
22021
12022
12023
12024
12026

FDA listed device types

showing 8 of 14
Active Implantable Bone Conduction Hearing System 1Hearing Aid, Bone Conduction 1Prosthesis, Nose, Internal 1Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Hearing Aid, Bone Conduction, Implanted 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Motor, Surgical Instrument, Ac-Powered 1Device, Percutaneous, Biopsy 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260902Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® System2026-07-10
USK240155Cochlear Osia System2024-04-18
USK231604Instrument Case2023-08-24

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