Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

60 results for "Starkey Laboratories, Inc."
1–24 of 60
Search insights Median review: 45d Cleared: 100% Top manufacturer: Starkey Laboratories, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 19, 2020
Multiflex Tinnitus Technology
K201370 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Sep 17, 2003
CRESCENT TINNITUS RETAINING SOUND GENERATOR
K030180 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 243d
Cleared May 02, 1997
PRECISE IMPRESSION KIT
K970952 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 49d
Cleared Feb 04, 1997
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
K964245 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 103d
Cleared Jan 10, 1997
PORTAREM-3000, PFS-6000
K964340 · EWO
Starkey Laboratories, Inc.
Ear, Nose, Throat · 71d
Cleared Dec 06, 1996
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
K964216 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 45d
Cleared Nov 27, 1996
STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION...
K964244 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d
Cleared Nov 27, 1996
STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION...
K964214 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 26, 1996
STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER
K963995 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 53d
Cleared Nov 26, 1996
STARKEY TM AIR CONDUCTION TINNITUS MASKER
K963838 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 63d
Cleared Sep 27, 1996
EUROLINE A-675 SERIS
K963519 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 24d
Cleared Mar 01, 1996
EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS
K960494 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 31d
Cleared Oct 21, 1994
PORTAREM 2000
K943460 · ETW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 95d
Cleared Oct 21, 1994
DESKREM-1000
K943459 · ETW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 95d
Cleared Oct 20, 1994
FEDELITY F495, VIENNATONE ALPP II
K943687 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 83d
Cleared Aug 17, 1994
SM-VEGA, SM-PC, SM-AGC, SM-AGC-H
K943682 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 22d
Cleared Aug 09, 1994
STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID
K940667 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 174d
Cleared Jul 05, 1994
STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID
K942594 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d
Cleared Jun 24, 1994
EUROSTAR SUPER, EUROSTAR VFC
K942036 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 57d
Cleared May 13, 1994
PRO-CONNECT
K932269 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 367d
Cleared May 10, 1994
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
K935701 · LXB
Starkey Laboratories, Inc.
Ear, Nose, Throat · 161d
Cleared May 04, 1994
MINI PAK
K941636 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared May 04, 1994
INTRA S, INTRA SH
K941635 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared May 04, 1994
STARKEY EUROLINE A SERIES
K940978 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 64d