Starkey Laboratories

FDA Regulatory Profile

Starkey Laboratories appears in FDA public data with 0 recalls, 61 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Jun 19, 2020.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K201370Multiflex Tinnitus TechnologyJun 19, 2020
K122876MULTIFLEX TINNITUS TECHNOLOGYOct 31, 2012
K030180CRESCENT TINNITUS RETAINING SOUND GENERATORSep 17, 2003
K970952PRECISE IMPRESSION KITMay 2, 1997
K964245PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITSFeb 4, 1997
K964340PORTAREM-3000, PFS-6000Jan 10, 1997
K964216STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKERDec 6, 1996
K964244STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDSNov 27, 1996
K964214STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDSNov 27, 1996
K963995STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKERNov 26, 1996
K963838STARKEY TM AIR CONDUCTION TINNITUS MASKERNov 26, 1996
K963519EUROLINE A-675 SERISSep 27, 1996
K960494EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDSMar 1, 1996
K943459DESKREM-1000Oct 21, 1994
K943460PORTAREM 2000Oct 21, 1994
K943687FEDELITY F495, VIENNATONE ALPP IIOct 20, 1994
K943682SM-VEGA, SM-PC, SM-AGC, SM-AGC-HAug 17, 1994
K940667STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AIDAug 9, 1994
K942594STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AIDJul 5, 1994
K942036EUROSTAR SUPER, EUROSTAR VFCJun 24, 1994