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
3409–3432 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Aug 31, 1981
CARL ZEISS INN MYRINGOTOMY TUBE LINE
K811698 · ETD
James L. Geraci & Associates, Inc.
Ear, Nose, Throat · 76d
Cleared Aug 21, 1981
ARGON MICROSURIGAL PROTOCOLS
K810740 · EWG
Lumenis, Inc.
Ear, Nose, Throat · 155d
Cleared Jul 28, 1981
MACHIDA NASOPHARYNGO-LARYNGOSCOPE
K811943 · EQN
Machida America, Inc.
Ear, Nose, Throat · 21d
Cleared Jul 28, 1981
EAGLE I HEARING AID
K811988 · ESD
Electone, Inc.
Ear, Nose, Throat · 15d
Cleared Jul 27, 1981
CUSTOM IN-THE-EAR HEARING AID
K811719 · ESD
Hearing Health Group, Inc.
Ear, Nose, Throat · 39d
Cleared Jul 27, 1981
SKIN STAPLE EXTRACTOR
K811887 · KBC
Sierra Laboratories, Inc.
Ear, Nose, Throat · 26d
Cleared Jul 15, 1981
PORTABLE AUDIOMETERS
K811727 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 27d
Cleared Jul 15, 1981
FINETONE MODEL VI HEARING AID
K811751 · ESD
Vicon Instrument Co.
Ear, Nose, Throat · 23d
Cleared Jul 15, 1981
AUDITORY LOCALIZER
K811772 · ETS
Western Advanced Technology, Inc.
Ear, Nose, Throat · 23d
Cleared Jul 15, 1981
OCTOTOXIC SCREENER
K811790 · ETS
Western Advanced Technology, Inc.
Ear, Nose, Throat · 21d
Cleared Jul 01, 1981
TELESONIC & ARCON
K811031 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 76d