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
2209–2232 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 22, 1991
BELTONE CLEARVOICE
K914940 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 18d
Cleared Nov 19, 1991
EXMOOR SILICONE RUBBER SHEET
K911503 · KHJ
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 230d
Cleared Nov 19, 1991
KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)
K911795 · LXV
Breg, Inc.
Ear, Nose, Throat · 211d
Cleared Nov 05, 1991
IN-THE-EAR HEARING AIDS
K913366 · ESD
Fenwick Hearing Instruments
Ear, Nose, Throat · 99d
Cleared Nov 05, 1991
EARSCAN DSP-1 PURE TONE AUDIOMETER
K913589 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 85d
Cleared Nov 05, 1991
HEARING AID, UNITRON MODEL VISTA 3000
K914688 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 18d
Cleared Nov 05, 1991
HEARING AID, UNITRON MODEL VISTA 4000
K914689 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 18d
Cleared Nov 05, 1991
P54 BTE HEARING AID
K914800 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 13d
Cleared Nov 01, 1991
TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC
K913494 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 87d
Cleared Nov 01, 1991
TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC
K913495 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 87d
Cleared Oct 24, 1991
OES THORACOSCOPE SYSTEM
K912362 · EWY
Olympus Corp.
Ear, Nose, Throat · 148d
Cleared Oct 23, 1991
PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION
K911726 · KHL
Bausch & Lomb, Inc.
Ear, Nose, Throat · 195d
Cleared Oct 21, 1991
MODEL 330 SCREENING AUDIOMETER
K911689 · EWO
Virtual Corp.
Ear, Nose, Throat · 188d
Cleared Oct 21, 1991
MICROTEK MEDICAL'S SOUND STIKS
K913276 · EWO
Microbio-Medics, Inc.
Ear, Nose, Throat · 90d
Cleared Oct 21, 1991
ACT-II BEHIND THE EAR HEARING AID
K914418 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 18d
Cleared Oct 21, 1991
AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID
K914477 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 13d
Cleared Oct 18, 1991
MODEL 80 HEARING AID DISPENSING SYSTEM
K913245 · ESD
3M Company
Ear, Nose, Throat · 88d
Cleared Oct 17, 1991
PEDIA PALS
K911650 · ERA
Pedia Pals, Inc.
Ear, Nose, Throat · 188d
Cleared Oct 15, 1991
CERAVITAL MIDDLE EAR IMPLANT
K913619 · ETB
Friedrichsfeld Medizintechnik AG
Ear, Nose, Throat · 63d
Cleared Oct 11, 1991
TYPE FA10 AUDIOMETER
K913221 · EWO
Frye Electronics, Inc.
Ear, Nose, Throat · 84d
Cleared Oct 11, 1991
SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION
K914333 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 14d
Cleared Sep 24, 1991
PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER
K910536 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 228d
Cleared Sep 24, 1991
DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES
K911580 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 174d
Cleared Sep 23, 1991
UC312, ULTRA MINIATURE ITC HEARING AID
K914017 · ESD
Qualitone
Ear, Nose, Throat · 14d