FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,812 results
3385–3408 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Mar 01, 1982
RIONET HEARING AID HB-71H
K820349 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 01, 1982
RIONET HEARING AID HB-71S
K820350 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 01, 1982
ATMOS MIRROR WARMER
K820354 · KAI
Jedmed Instrument Co.
Ear, Nose, Throat · 21d
Cleared Feb 24, 1982
PHONIC EAR MODEL PE 810S
K820172 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 34d
Cleared Feb 23, 1982
MODEL 343 HEARING AID
K820148 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 35d
Cleared Feb 22, 1982
MODEL 3000C CALORIC IRRIGATOR
K813552 · ETP
Life-Tech Intl., Inc.
Ear, Nose, Throat · 63d
Cleared Jan 22, 1982
CONPHAR LARYNGOSCOPE
K813297 · EQN
Conphar, Inc.
Ear, Nose, Throat · 60d
Cleared Jan 22, 1982
TEKNA MED MYRINGOTOMY DISPOS-OTO KIT
K813616 · ETD
Humboldt Products
Ear, Nose, Throat · 24d
Cleared Jan 22, 1982
BOSCH TOP STAR III
K820041 · ESD
Bosch Hearing Instruments, Inc.
Ear, Nose, Throat · 15d
Cleared Jan 19, 1982
CONPHAR OTOSCOPE/OPTHALMASCOPE
K813299 · ERA
Conphar, Inc.
Ear, Nose, Throat · 57d
Cleared Jan 19, 1982
CONPHAR OTOSCOPE
K813305 · ERA
Conphar, Inc.
Ear, Nose, Throat · 57d
Cleared Jan 19, 1982
POST-AURICULAR HEARING AID MODEL P-101
K813329 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 56d
Cleared Jan 19, 1982
POST-AURICULAR HEARING AID MODEL S-101
K813330 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 56d
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