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
2065–2088 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 16, 1992
HEARING AID (ALL-IN-THE-EAR)
K924350 · ESD
Ear Masters, Inc.
Ear, Nose, Throat · 81d
Cleared Nov 09, 1992
XOMED-TREACE ALPHASCOPE
K923830 · ERA
Xomed-Treace, Inc.
Ear, Nose, Throat · 101d
Cleared Nov 06, 1992
OTO-BRITE HANDLE
K924025 · ERA
Jedmed Instrument Co.
Ear, Nose, Throat · 87d
Cleared Nov 06, 1992
AAHS HEARING AID
K925103 · ESD
American Hearing Systems, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 05, 1992
ST 20 PORTABLE AUDIOMETER
K922746 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 150d
Cleared Nov 04, 1992
PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT
K924911 · ESD
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 04, 1992
PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR
K924913 · ESD
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 04, 1992
PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT
K924914 · ESD
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 03, 1992
DFS GENIUS BTE
K924185 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 75d
Cleared Nov 03, 1992
PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT
K924912 · ESD
Phonak, Inc.
Ear, Nose, Throat · 35d
Cleared Nov 02, 1992
321Q MINIMUM ENERGY TINNITUS SUPPRESSOR
K922572 · KLW
Microbio-Medics, Inc.
Ear, Nose, Throat · 154d
Cleared Oct 26, 1992
SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR
K922037 · LXV
Micromedical Technologies, Inc.
Ear, Nose, Throat · 178d
Cleared Oct 21, 1992
FAMILY EAR SCOPE MODEL 29001S
K923304 · ERA
Ear Care of So. Ca., Inc.
Ear, Nose, Throat · 107d
Cleared Oct 19, 1992
DISPOSABLE ENDOILLUMINATOR
K923774 · EQH
O.R. Specialties, Inc.
Ear, Nose, Throat · 83d
Cleared Oct 06, 1992
DISPOSABLE PROTECTIVE SHEATH
K921244 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 204d
Cleared Oct 06, 1992
PHARYNGEAL SALIVARY BYPASS TUBE
K923355 · KCF
Boston Medical Products, Inc.
Ear, Nose, Throat · 90d
Cleared Oct 05, 1992
OTOVENT
K920840 · MJV
Abigo Medical AB
Ear, Nose, Throat · 224d
Cleared Oct 05, 1992
ITC HEARING AID CLUB MODEL LM50
K923292 · ESD
Club Hearing Instruments A/S
Ear, Nose, Throat · 95d
Cleared Oct 05, 1992
MEDIPHONIX CUSTOM FULL SHELL CUSTOM CANAL
K924450 · ESD
Mediphonix, Inc.
Ear, Nose, Throat · 35d
Cleared Sep 30, 1992
NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION
K912508 · ETN
Rln Systems, Inc.
Ear, Nose, Throat · 482d
Cleared Sep 29, 1992
PE 400IR, PE 400T, PE 400E
K923234 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 90d
Cleared Sep 28, 1992
DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT
K923071 · ESD
Life-Tech Intl., Inc.
Ear, Nose, Throat · 95d
Cleared Sep 28, 1992
SOUNDCHOICE K-AMP
K923735 · ESD
Bausch & Lomb, Inc.
Ear, Nose, Throat · 63d
Cleared Sep 28, 1992
BTE WITH ACCESSORY ATTACHED
K923743 · ESD
Phonak, Inc.
Ear, Nose, Throat · 63d