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
2401–2424 of 3,823
Search insights Median review: 65d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Oct 09, 1990
ITE HEARING AID, DIAMOND MODEL
K903859 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
ITE HEARING AID, SAAPHIRE MODEL
K903860 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
ITE HEARING AID, SOUND MED GOLDEN NUGGET MODEL
K903861 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
ITE HEARING AID, SOUND MED RUBY MODEL
K903862 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
ITE HEARING AID, SOUND MED OPAL MODEL
K903863 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
ITE HEARING AID, PEARL MODEL
K903864 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
ITE HEARING AID, SOUND MED AMETHYST MODEL
K903865 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 09, 1990
BIOLINK AUDIOMETER SOFTWARE ACCESSORY
K904270 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 21d
Cleared Oct 05, 1990
RASTRONICS CCI 8
K902244 · ETW
Rastronics USA, Inc.
Ear, Nose, Throat · 140d
Cleared Oct 05, 1990
MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM
K903760 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 46d
Cleared Sep 26, 1990
MICRO BRIGHT VENTILATION TUBES
K903285 · ETD
Invotec International, Inc.
Ear, Nose, Throat · 64d
Cleared Sep 19, 1990
OTOSCREENER-I AND OTO-SCREEN-I-P
K903143 · EWO
Handtronix, Inc.
Ear, Nose, Throat · 63d
Cleared Sep 12, 1990
DYNASTY HEARING SYSTEMS INSTRUMENT
K900632 · ESD
Alastair Granville-Jackson, Mfa, Ed.D.
Ear, Nose, Throat · 216d
Cleared Sep 12, 1990
RASTRONICS CCI 10/3 HEARING AID ANALYSIS
K902252 · ETW
Rastronics USA, Inc.
Ear, Nose, Throat · 114d
Cleared Sep 12, 1990
FIBER OPTIC LIGHT SOURCE
K902784 · EQH
Trek Medical Products, Inc.
Ear, Nose, Throat · 78d
Cleared Sep 05, 1990
ESCORT ITC
K903295 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 42d
Cleared Aug 14, 1990
OTOSCOPE
K902205 · ERA
Truphatek, Ltd.
Ear, Nose, Throat · 90d
Cleared Aug 10, 1990
VISTA - MODELS V12, V20, V23, V38, ITE HEARING AID
K902179 · ESD
Vista Laboratories, Inc.
Ear, Nose, Throat · 87d
Cleared Aug 09, 1990
CAS (COMPUTERIZED ANALYZER SYSTEM)
K896996 · ETW
Gn Danavox, Inc.
Ear, Nose, Throat · 241d
Cleared Aug 09, 1990
MODIFIED BIVONA EPISTAXIS CATHETER
K900583 · EMX
Bivona Medical Technologies
Ear, Nose, Throat · 183d
Cleared Aug 09, 1990
CE-8 CUSTOM IN-THE-EAR HEARING AIDS
K901833 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 107d
Cleared Aug 06, 1990
HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER
K902068 · EWO
Starkey Laboratories, Inc.
Ear, Nose, Throat · 91d
Cleared Aug 01, 1990
BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT
K902112 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 84d
Cleared Aug 01, 1990
ITE HEARING AID MODEL PALOMINO
K902290 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d