FDA.reportPublic FDA data

STARKEY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21256082125608Starkey Laboratories, Inc.1Y2026-01-016700 Washington Ave S EDEN PRAIRIE MN US 55344
21837322183732STARKEY GLENCOE1N2026-01-012915 10th St E GLENCOE MN US 55336
30065443643006544364STARKEY (Suzhou) Hearing Technology Co, LTD.1N2026-01-011st Floor and East Unit of 2nd Floor Building 1, No. 588, Shenjiawan Road Guoxiang, Wuzhong District, Suzhou Jiangsu CN 215124
30196225833019622583Starkey Global Distribution Center1Y2026-01-013810 Plainfield Road, Suite#112 Plainfield IN US 46168
30039171063003917106STARKEY LABS BROWNSVILLE DISTRIBUTION CENTER1N2020-04-25615 Elca Ln Ste A BROWNSVILLE TX US 78521

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2940121184990517K201370Multiflex Tinnitus TechnologyKLW2020-06-19
58991184990517K201370Multiflex Tinnitus TechnologyKLW2020-06-19
356041184990517K201370Multiflex Tinnitus TechnologyKLW2020-06-19
58991277267197K122876MULTIFLEX TINNITUS TECHNOLOGYKLW2012-10-31
2940121277267197K122876MULTIFLEX TINNITUS TECHNOLOGYKLW2012-10-31
356041277267197K122876MULTIFLEX TINNITUS TECHNOLOGYKLW2012-10-31
59091277267197K122876MULTIFLEX TINNITUS TECHNOLOGYKLW2012-10-31
59091517697302
59091598703598
59091752855977
356041517697302
59001517697302
58991517697302
2940121517697302
356041598703598
59001598703598
2940121598703598
58991598703598

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KLW72020-06-19

PMN#

MINI PAK

1994-05-04

STARKEY LABORATORIES, INC.

61 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next