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
2401–2424 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Jul 27, 1990
REXTON RX12 POWER PLUS W/DUAL RECEIVER
K901341 · ESD
Rexton, Inc.
Ear, Nose, Throat · 127d
Cleared Jul 27, 1990
HERITAGE III (HTC) ITC TYPE HEARING AID
K903023 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 20, 1990
INTRA III AND INTRA IV HEARING AIDS
K901860 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 87d
Cleared Jul 13, 1990
GSI 17 SCREENING AUDIOMETER
K902540 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 37d
Cleared Jul 09, 1990
CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P
K902559 · ESD
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Jul 09, 1990
ADAM MARK II CUSTOM IN-THE-EAR HEARING AID
K902570 · ESD
Adams Hearing Aid Center
Ear, Nose, Throat · 31d
Cleared Jun 28, 1990
ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM
K901503 · ESE
Stanton Magnetics, Inc.
Ear, Nose, Throat · 90d
Cleared Jun 28, 1990
ELECTROGLOTTOGRAPH
K901609 · KLX
Glottal Ent., Inc.
Ear, Nose, Throat · 83d
Cleared Jun 26, 1990
AUDIOTESTER SCREENING AUDIOMETER
K894484 · EWO
Prometex, Inc.
Ear, Nose, Throat · 343d
Cleared Jun 14, 1990
EXPANDACEL NASAL TAMPONS
K900171 · EMX
Surgitrend, Ltd.
Ear, Nose, Throat · 153d
Cleared Jun 14, 1990
JAHN VENTILATION TUBE
K900267 · ETD
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 147d