Medical Device Manufacturer · US , Mchenry , IL

Starkey Laboratories, Inc.

60 submissions · 60 cleared · Since 1977
60
Total
60
Cleared
0
Denied

Starkey Laboratories, Inc. — FDA 510(k) Submissions

Starkey Laboratories, Inc. has submitted 60 FDA 510(k) premarket notifications since 1977, of which 60 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hearing Aid, Air-conduction, Prescription, Masker, Tinnitus, Calibrator, Hearing Aid / Earphone And Analysis Systems, Audiometer, Hearing Aid, Bone Conduction . Use the specialty filter in the sidebar to narrow results.

60 devices
1–25 of 60
Multiflex Tinnitus Technology
K201370 · KLW Masker, Tinnitus · Ear, Nose, Throat
Jun 2020 28d
CRESCENT TINNITUS RETAINING SOUND GENERATOR
K030180 · KLW Masker, Tinnitus · Ear, Nose, Throat
Sep 2003 243d
PRECISE IMPRESSION KIT
K970952 · ESD Hearing Aid,... · Ear, Nose, Throat
May 1997 49d
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
K964245 · ESD Hearing Aid,... · Ear, Nose, Throat
Feb 1997 103d
PORTAREM-3000, PFS-6000
K964340 · EWO Audiometer · Ear, Nose, Throat
Jan 1997 71d
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
K964216 · KLW Masker, Tinnitus · Ear, Nose, Throat
Dec 1996 45d
STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
K964214 · ESD Hearing Aid,... · Ear, Nose, Throat
Nov 1996 36d
STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
K964244 · ESD Hearing Aid,... · Ear, Nose, Throat
Nov 1996 34d
STARKEY TM AIR CONDUCTION TINNITUS MASKER
K963838 · KLW Masker, Tinnitus · Ear, Nose, Throat
Nov 1996 63d
STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER
K963995 · KLW Masker, Tinnitus · Ear, Nose, Throat
Nov 1996 53d
EUROLINE A-675 SERIS
K963519 · ESD Hearing Aid,... · Ear, Nose, Throat
Sep 1996 24d
EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS
K960494 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1996 31d
DESKREM-1000
K943459 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
Oct 1994 95d
PORTAREM 2000
K943460 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
Oct 1994 95d
FEDELITY F495, VIENNATONE ALPP II
K943687 · ESD Hearing Aid,... · Ear, Nose, Throat
Oct 1994 83d
SM-VEGA, SM-PC, SM-AGC, SM-AGC-H
K943682 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1994 22d
STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID
K940667 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1994 174d
STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID
K942594 · ESD Hearing Aid,... · Ear, Nose, Throat
Jul 1994 34d
EUROSTAR SUPER, EUROSTAR VFC
K942036 · ESD Hearing Aid,... · Ear, Nose, Throat
Jun 1994 57d
PRO-CONNECT
K932269 · ESD Hearing Aid,... · Ear, Nose, Throat
May 1994 367d
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
K935701 · LXB Hearing Aid, Bone Conduction · Ear, Nose, Throat
May 1994 161d
STARKEY EUROLINE A SERIES
K940978 · ESD Hearing Aid,... · Ear, Nose, Throat
May 1994 64d
INTRA S, INTRA SH
K941635 · ESD Hearing Aid,... · Ear, Nose, Throat
May 1994 30d
MINI PAK
K941636 · ESD Hearing Aid,... · Ear, Nose, Throat
May 1994 30d
OMNI 2000 SERIES ITE HEARING AID
K934416 · ESD Hearing Aid,... · Ear, Nose, Throat
Nov 1993 77d
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