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
3409–3432 of 3,823
Search insights Median review: 65d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 19, 1982
AUDITORY STIMULATOR
K813557 · ETS
Western Advanced Technology, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 12, 1982
RIONET HEARING AID HI-62
K813546 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Jan 12, 1982
PHONIC EAR MODEL PE805CD
K813583 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 15d
Cleared Jan 07, 1982
VERSION OF A CLOSED-FLOW SYS. CALORIC
K813490 · ETF
Thomas M. Foti, M.D.
Ear, Nose, Throat · 34d
Cleared Dec 31, 1981
CUSTOM-IN-THE-EAR HEARING AID
K813316 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 37d
Cleared Dec 31, 1981
POST-AURICULAR HEARING AID MODEL ASP-103
K813344 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 36d
Cleared Dec 08, 1981
HEARING AID CUSTOM ITE
K813206 · ESD
Duvan Acoustics, Inc.
Ear, Nose, Throat · 25d
Cleared Dec 08, 1981
HEARING AID MODEL UE9-R
K813229 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 28d
Cleared Dec 03, 1981
HELP-MATE
K813249 · ESD
G & W Applied Science Laboratories
Ear, Nose, Throat · 15d
Cleared Dec 02, 1981
VIBRO-COM COMMUNICATOR #8827
K813057 · LRA
Sonic Systems, Inc.
Ear, Nose, Throat · 34d
Cleared Nov 24, 1981
SILASTIC VOICE PROSTHESIS
K812864 · EWL
Dow Corning Corp. Healthcare...
Ear, Nose, Throat · 42d
Cleared Nov 24, 1981
BLOM-SINGER VOICE PROSTHESIS
K812982 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 32d
Cleared Nov 06, 1981
BEHIND-THE-EAR MODEL 115
K812937 · ESD
Danavox, Inc.
Ear, Nose, Throat · 17d
Cleared Nov 06, 1981
IN-THE-EAR MODEL 821
K812938 · ESD
Danavox, Inc.
Ear, Nose, Throat · 17d
Cleared Nov 06, 1981
IN-THE-EAR MODEL 101M
K812939 · ESD
Danavox, Inc.
Ear, Nose, Throat · 17d
Cleared Nov 06, 1981
P.P.P. TREATMENT CABINET
K813003 · ERA
Precision Professional Products
Ear, Nose, Throat · 11d
Cleared Nov 02, 1981
YARMO NASAL CARTILAGE SOFTENER
K812895 · KAE
American V. Mueller
Ear, Nose, Throat · 18d
Cleared Oct 19, 1981
MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P
K812734 · EQN
Machida America, Inc.
Ear, Nose, Throat · 20d
Cleared Oct 14, 1981
EARSCAN
K812529 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 42d
Cleared Oct 02, 1981
ELEGANCE
K812578 · ESD
Qualitone
Ear, Nose, Throat · 23d
Cleared Sep 25, 1981
EXMOOR AURAL GROMMET AG/TI
K812459 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 25d
Cleared Sep 23, 1981
DALE COMBO TRACHEOSTOMY TUBE HOLDER
K812429 · EQH
Dale Medical Products, Inc.
Ear, Nose, Throat · 29d
Cleared Sep 21, 1981
VARIOUS AURAL GROMMETS
K812460 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 21d
Cleared Sep 08, 1981
MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE
K812305 · KCF
Boston Medical Products, Inc.
Ear, Nose, Throat · 22d