FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,798 results
2017–2040 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 07, 1993
HEARING AID (ALL-IN-THE-EAR)
K930542 · ESD
Action Labs, Inc.
Ear, Nose, Throat · 64d
Cleared Apr 07, 1993
RIONET HEARING AID HB-53S
K930721 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 55d
Cleared Mar 26, 1993
CANNULATED BIOPSY FORCEPS
K926430 · EOQ
Thomasville Medical Assoc.
Ear, Nose, Throat · 93d
Cleared Mar 19, 1993
HOUSE-BELLUCCI ALLIGATOR SCISSORS
K930292 · LRC
Thomasville Medical Assoc.
Ear, Nose, Throat · 57d
Cleared Mar 18, 1993
MEROCEL EPISTACIS KIT
K920394 · EMX
Merocel Corp.
Ear, Nose, Throat · 413d
Cleared Mar 18, 1993
ATTIC DEFECT PLATE
K921433 · ETC
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 358d
Cleared Mar 18, 1993
HANDTYMP
K923072 · ETY
Life-Tech Intl., Inc.
Ear, Nose, Throat · 266d
Cleared Mar 18, 1993
BEHIND-THE-EAR HEARING AID
K930271 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 58d
Cleared Mar 18, 1993
OTOSONIC FSD, IN-THE-EAR HEARING AID
K930598 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 41d
Cleared Mar 18, 1993
WIDEX MODEL DX HEARING AID
K930715 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 35d
Cleared Mar 18, 1993
CE-9 IN-THE-EAR HEARING AID
K930805 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared Mar 18, 1993
INTRA V AND SECRET EAR III
K930853 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Mar 16, 1993
FLEXIBLE TROCAR TUBES
K930215 · EWY
Olympus Corp.
Ear, Nose, Throat · 61d
Cleared Mar 08, 1993
INCUDOSTAPEDIAL JOINT
K925443 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 131d
Cleared Mar 04, 1993
AUDIOSCAN
K926336 · EWO
Electrocaine Medical System
Ear, Nose, Throat · 78d
Cleared Mar 03, 1993
VOICEMODE, ITE, AIR-CONDUCTION HEARING AID
K930541 · ESD
Personal Sound Technologies, Inc.
Ear, Nose, Throat · 29d
Cleared Mar 01, 1993
BELTONE OPTIMA 2000 CLEARVOICE SERIES, IN-THE-EAR
K930310 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 38d
Cleared Mar 01, 1993
BELTONE OPERA LOR, ITC
K930318 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 38d
Cleared Feb 26, 1993
AT-2
K923007 · EWO
Qualitone
Ear, Nose, Throat · 249d
Cleared Feb 26, 1993
DSP SCREENING AUDIOMETER
K924543 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 171d
Cleared Feb 19, 1993
AUTOMATIC TYMPANOMETER
K923073 · ETY
Life-Tech Intl., Inc.
Ear, Nose, Throat · 239d
Cleared Feb 19, 1993
JACK'S VENT TUBES
K923887 · ETD
O.R. Specialties, Inc.
Ear, Nose, Throat · 199d
Cleared Feb 12, 1993
AMERICAN ARTIFICIAL LARYNX
K914816 · ESE
Ultravoice, Ltd.
Ear, Nose, Throat · 476d
Cleared Feb 12, 1993
TITANIUM VENTILATION TUBES
K921923 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 310d