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
1225–1248 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Mar 31, 1997
AUDALLION II HEARING SYSTEM
K970215 · ESD
Resound Corp.
Ear, Nose, Throat · 69d
Cleared Mar 31, 1997
MULTI-CHANNEL COMPRESSION BTE (SD)
K970262 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 67d
Cleared Mar 28, 1997
FAST TRACT TRANSTRACHEAL PROCEDURE KIT
K970018 · LRC
L.W. Ward and Assoc., Inc.
Ear, Nose, Throat · 85d
Cleared Mar 28, 1997
REXTON MODEL 48 AND 49PP
K970537 · ESD
Rexton, Inc.
Ear, Nose, Throat · 44d
Cleared Mar 26, 1997
AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER
K970340 · LZI
Bellab
Ear, Nose, Throat · 56d
Cleared Mar 26, 1997
WIDEX SENSO DIGITAL (CIC)
K970904 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 14d
Cleared Mar 21, 1997
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
K970247 · EOB
Smith & Nephew, Inc.
Ear, Nose, Throat · 58d
Cleared Mar 18, 1997
RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK...
K970279 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 54d
Cleared Mar 17, 1997
IL0292 DP ECHOPORT
K970555 · EWO
Smith
Ear, Nose, Throat · 32d
Cleared Mar 12, 1997
WIDEX MODEL SENSO DIGITAL (C9)
K965254 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 72d
Cleared Mar 11, 1997
ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI
K970430 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 35d
Cleared Mar 10, 1997
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K964909 · ETB
Xomed, Inc.
Ear, Nose, Throat · 91d
Cleared Mar 10, 1997
ROUND WINDOW CATH
K965115 · ETD
Neuro-Biometrix, Inc.
Ear, Nose, Throat · 80d
Cleared Feb 26, 1997
AHS OMEGA SP
K970057 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 50d
Cleared Feb 12, 1997
BREATHE FIT
K963326 · LWF
Cambridge Assoc.
Ear, Nose, Throat · 173d
Cleared Feb 11, 1997
HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER
K963727 · ETD
Medtronic Xomed
Ear, Nose, Throat · 148d
Cleared Feb 11, 1997
SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO,...
K964657 · ESD
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 83d
Cleared Feb 04, 1997
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
K964245 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 103d
Cleared Feb 04, 1997
MIRACLE - EAR (ITE/ITC/CIC)
K964419 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 126d
Cleared Feb 03, 1997
SMARTOAE
K964426 · EWO
Intelligent Hearing Systems
Ear, Nose, Throat · 90d
Cleared Jan 27, 1997
DAHLBERG (A-554)
K965049 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 27, 1997
AUDIOTONE (A554H)
K965057 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 27, 1997
AUDIOTONE (A-552)
K965063 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 24, 1997
KARTUSH TM PATCHER
K964484 · KHJ
Xomed, Inc.
Ear, Nose, Throat · 78d