Starkey Laboratories, Inc.

FDA 510(k) & PMA Approved Devices — 60 products

Total Devices60

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K201370	Multiflex Tinnitus Technology	KLW	2020-06-19	View
510(k)	K030180	CRESCENT TINNITUS RETAINING SOUND GENERATOR	KLW	2003-09-17	View
510(k)	K970952	PRECISE IMPRESSION KIT	ESD	1997-05-02	View
510(k)	K964245	PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS	ESD	1997-02-04	View
510(k)	K964340	PORTAREM-3000, PFS-6000	EWO	1997-01-10	View
510(k)	K964216	STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER	KLW	1996-12-06	View
510(k)	K964244	STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS	ESD	1996-11-27	View
510(k)	K964214	STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS	ESD	1996-11-27	View
510(k)	K963838	STARKEY TM AIR CONDUCTION TINNITUS MASKER	KLW	1996-11-26	View
510(k)	K963995	STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER	KLW	1996-11-26	View
510(k)	K963519	EUROLINE A-675 SERIS	ESD	1996-09-27	View
510(k)	K960494	EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS	ESD	1996-03-01	View
510(k)	K943460	PORTAREM 2000	ETW	1994-10-21	View
510(k)	K943459	DESKREM-1000	ETW	1994-10-21	View
510(k)	K943687	FEDELITY F495, VIENNATONE ALPP II	ESD	1994-10-20	View
510(k)	K943682	SM-VEGA, SM-PC, SM-AGC, SM-AGC-H	ESD	1994-08-17	View
510(k)	K940667	STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID	ESD	1994-08-09	View
510(k)	K942594	STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID	ESD	1994-07-05	View
510(k)	K942036	EUROSTAR SUPER, EUROSTAR VFC	ESD	1994-06-24	View
510(k)	K932269	PRO-CONNECT	ESD	1994-05-13	View