Home / Companies / Starkey Laboratories, Inc.

Starkey Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
61
Inspections
6
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K201370Multiflex Tinnitus TechnologyJune 19, 2020
K122876MULTIFLEX TINNITUS TECHNOLOGYOctober 31, 2012
K030180CRESCENT TINNITUS RETAINING SOUND GENERATORSeptember 17, 2003
K970952PRECISE IMPRESSION KITMay 2, 1997
K964245PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITSFebruary 4, 1997
K964340PORTAREM-3000, PFS-6000January 10, 1997
K964216STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKERDecember 6, 1996
K964214STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDSNovember 27, 1996
K964244STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDSNovember 27, 1996
K963838STARKEY TM AIR CONDUCTION TINNITUS MASKERNovember 26, 1996
K963995STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKERNovember 26, 1996
K963519EUROLINE A-675 SERISSeptember 27, 1996
K960494EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDSMarch 1, 1996
K943460PORTAREM 2000October 21, 1994
K943459DESKREM-1000October 21, 1994
K943687FEDELITY F495, VIENNATONE ALPP IIOctober 20, 1994
K943682SM-VEGA, SM-PC, SM-AGC, SM-AGC-HAugust 17, 1994
K940667STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AIDAugust 9, 1994
K942594STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AIDJuly 5, 1994
K942036EUROSTAR SUPER, EUROSTAR VFCJune 24, 1994