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."
25–48 of 60
Search insights Median review: 45d Cleared: 100% Top manufacturer: Starkey Laboratories, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 29, 1993
OMNI 2000 SERIES ITC HEARING AID
K934417 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 77d
Cleared Nov 29, 1993
OMNI 2000 SERIES ITE HEARING AID
K934416 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 77d
Cleared Oct 07, 1993
RESOLUTION ITC HEARING AID
K933989 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 51d
Cleared Oct 07, 1993
BOSCH EUROSTAR
K933988 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 51d
Cleared Oct 07, 1993
STARKEY TYMPANETTE HEARING AID
K933407 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 87d
Cleared Jul 27, 1993
STARKEY TRILOGY II PROGRAMMABLE HEARING AID
K933113 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 32d
Cleared Mar 18, 1993
INTRA V AND SECRET EAR III
K930853 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Mar 18, 1993
CE-9 IN-THE-EAR HEARING AID
K930805 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared Sep 04, 1992
STARKEY LABORATORIES OTOSCOPE
K922752 · ERA
Starkey Laboratories, Inc.
Ear, Nose, Throat · 88d
Cleared Aug 26, 1992
STARKEY SM SERIES BTE HEARING AIDS
K923784 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 29d
Cleared May 07, 1991
STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS
K911579 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 35d
Cleared Dec 21, 1990
HEARSET TELEPHONE HEARING SYSTEM
K903145 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 156d
Cleared Aug 09, 1990
CE-8 CUSTOM IN-THE-EAR HEARING AIDS
K901833 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 107d
Cleared Aug 06, 1990
HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER
K902068 · EWO
Starkey Laboratories, Inc.
Ear, Nose, Throat · 91d
Cleared Jul 20, 1990
INTRA III AND INTRA IV HEARING AIDS
K901860 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 87d
Cleared Apr 11, 1988
STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES
K880969 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d
Cleared Mar 18, 1988
INTRA II SECRET EAR HEARING AIDS ISE
K880335 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 52d
Cleared Mar 18, 1988
CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7
K880334 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 52d
Cleared Mar 18, 1988
CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7
K880333 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 52d
Cleared Feb 08, 1988
STARKEY MODEL P1 MODULE
K873031 · LRB
Starkey Laboratories, Inc.
Ear, Nose, Throat · 188d
Cleared Dec 03, 1984
STARKET MODEL HMS
K844275 · ETW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Aug 03, 1982
STARKEY MODEL HAL-1
K821908 · ETW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 12, 1980
TINNITUS RESEARCH AUDIOMETER
K802560 · EWO
Starkey Laboratories, Inc.
Ear, Nose, Throat · 27d
Cleared Nov 27, 1979
MODEL TM2-BEHIND-THE-EAR TINNITUS
K792214 · BWF
Starkey Laboratories, Inc.
Anesthesiology · 25d