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
2281–2304 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared May 09, 1991
NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS
K911182 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 52d
Cleared May 07, 1991
STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS
K911579 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 35d
Cleared Apr 30, 1991
DR. DEDO'S FAMILY EAR EXAMINATION KIT
K904659 · ERA
Panex Corp.
Ear, Nose, Throat · 197d
Cleared Apr 30, 1991
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
K905704 · ETY
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 130d
Cleared Apr 29, 1991
BRONCHOSCOPE BF-N20
K910423 · EOQ
Olympus Corp.
Ear, Nose, Throat · 89d
Cleared Apr 22, 1991
X-T AIR DRILL
K905800 · ERL
Xomed-Treace, Inc.
Ear, Nose, Throat · 115d
Cleared Apr 19, 1991
AXOSTIM NERVE STIMULATOR, MODIFICATION
K905035 · ETN
Singer Medical Products, Inc.
Ear, Nose, Throat · 176d
Cleared Apr 19, 1991
CUSTOM PERSONAL EAR - CPE
K911497 · ESD
Qualitone
Ear, Nose, Throat · 18d
Cleared Apr 19, 1991
ADJUSTRETTE - DAO, MODIFICATION
K911498 · ESD
Qualitone
Ear, Nose, Throat · 21d
Cleared Apr 19, 1991
ELEGANCE - DEO, MODIFICATION
K911499 · ESD
Qualitone
Ear, Nose, Throat · 21d
Cleared Apr 19, 1991
ULTRA & ULTRA LITE II, MODIFICATION
K911504 · ESD
Qualitone
Ear, Nose, Throat · 16d
Cleared Apr 17, 1991
THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER
K900197 · EWO
Sound Linked Data, Inc.
Ear, Nose, Throat · 456d
Cleared Apr 17, 1991
MOBILE TREATMENT CART
K910243 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 85d
Cleared Apr 17, 1991
PHONAK 9800 SC-AF ITE HEARING INSTRUMENT
K911210 · ESD
Phonak, Inc.
Ear, Nose, Throat · 29d
Cleared Apr 17, 1991
PHONAK 9100 SC-AF ITE HEARING INSTRUMENT
K911211 · ESD
Phonak, Inc.
Ear, Nose, Throat · 29d
Cleared Apr 15, 1991
AHL, ITE MODEL AMERICAN
K910325 · ESD
Bob Bare Hearing Aid Repair
Ear, Nose, Throat · 81d
Cleared Apr 15, 1991
PHONAK 9300 SC-AF ITE HEARING INSTRUMENT
K911209 · ESD
Phonak, Inc.
Ear, Nose, Throat · 27d
Cleared Apr 09, 1991
MODEL FT40 TRANSONIC(TM) HEARING AID
K905516 · ESD
Sonovation, Inc. Dba Avr Sonovation
Ear, Nose, Throat · 123d
Cleared Apr 03, 1991
RESORBABLE BONE PLUG
K905740 · ESD
Zimmer, Inc.
Ear, Nose, Throat · 100d
Cleared Apr 03, 1991
ELECTONE ITE MODEL PREMIER
K910097 · ESD
Electone, Inc.
Ear, Nose, Throat · 84d
Cleared Mar 29, 1991
GSI 37 AUTO TYMP
K911095 · ETY
Lucas Grason-Stadler, Inc.
Ear, Nose, Throat · 16d
Cleared Mar 21, 1991
EXPANDACEL NASAL TAMPONS
K904624 · EMX
Ron Shippert, MD
Ear, Nose, Throat · 161d
Cleared Mar 21, 1991
DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID
K910809 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 23d
Cleared Mar 21, 1991
DAHLBERG MODEL LT BTE HEARING AID
K910979 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 14d