FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

Filters: Ear, Nose, Throat ×
3,823 results
3505–3528 of 3,823
Search insights Median review: 65d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 12, 1980
TINNITUS RESEARCH AUDIOMETER
K802560 · EWO
Starkey Laboratories, Inc.
Ear, Nose, Throat · 27d
Cleared Nov 12, 1980
OTOLOGICAL VENTILATION TUBES
K802587 · ETD
Humboldt Products
Ear, Nose, Throat · 23d
Cleared Nov 12, 1980
TELESONIC, ARCON & SOUNDEX ASP 102
K802596 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 22d
Cleared Nov 12, 1980
TELESONIC ARCON & SOUNDEX ASP 101
K802597 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 22d
Cleared Nov 12, 1980
OTOLOGICAL VENTILATION TUBES
K802638 · ETD
Santa Barbara Medco, Inc.
Ear, Nose, Throat · 21d
Cleared Oct 31, 1980
MICRO-SURGICAL POWER INSTRUMENT SYSTEM
K802463 · ERL
Spire Medical, Inc.
Ear, Nose, Throat · 22d
Cleared Oct 31, 1980
MICRO-SUGICAL POWER INSTRUMENT SYSTEM
K802503 · EQJ
Spire Medical, Inc.
Ear, Nose, Throat · 14d
Cleared Oct 23, 1980
ATTENU-CHEK
K802350 · EWO
Hear Co., Inc.
Ear, Nose, Throat · 28d
Cleared Oct 23, 1980
NEBULIZER, MEDICINAL
K802430 · EPN
Dhd Medical Products Div. Diemolding...
Ear, Nose, Throat · 17d
Cleared Oct 23, 1980
DAHLBERG HEARING AID MODEL AI
K802510 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Oct 10, 1980
CO2 MICROSURGICAL LASER SYSTEM #370
K802034 · EWG
Metricon, Ltd.
Ear, Nose, Throat · 49d
Cleared Oct 10, 1980
SELF-RECORDING ADMITTANCE METER 709
K802097 · ETY
Amplaid USA, Inc.
Ear, Nose, Throat · 38d
Cleared Oct 10, 1980
BEDSIDE TINNITUS MASKER #1500
K802234 · KLW
Marpac, Inc.
Ear, Nose, Throat · 25d
Cleared Oct 10, 1980
WIDEX HEARING AID #'S A18+T & A18+H
K802306 · ESD
Hearing Aid Co.
Ear, Nose, Throat · 17d
Cleared Oct 10, 1980
WIDEX HEARING AID #'S A12+T & A12+H
K802307 · ESD
Hearing Aid Co.
Ear, Nose, Throat · 17d
Cleared Oct 10, 1980
E1 SERIES HEARING AID
K802324 · ESD
Western Advanced Technology, Inc.
Ear, Nose, Throat · 17d
Cleared Sep 26, 1980
RIONET HEARING AID HB-69C
K802053 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 32d
Cleared Sep 26, 1980
RION DIAGNOSTIC AUDIOMETER
K802207 · EWO
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 15d
Cleared Sep 16, 1980
PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A
K801866 · EQL
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 42d
Cleared Sep 09, 1980
RHINOMETER
K801938 · JYJ
Aztec Medical Products, Inc.
Ear, Nose, Throat · 28d
Cleared Sep 09, 1980
RIONET HEARING AID HB-70H
K801958 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 48d
Cleared Aug 27, 1980
FONIX TYPE 5100 HEARING AID ANALYZER
K801905 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 16d
Cleared Aug 14, 1980
RIONET HEARING AID AND/OR RION #HB-70
K801692 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Aug 13, 1980
NOBLE MEDEL ENT TREATMENT UNIT
K801738 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 19d