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
1249–1272 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Jan 24, 1997
COMFORTAID HEARING AID
K964680 · ESD
Ethical Hearing Instruments
Ear, Nose, Throat · 63d
Cleared Jan 24, 1997
M11 SERIES: M11, M11M
K965088 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 36d
Cleared Jan 24, 1997
SENSO DIGITAL (C18)
K965218 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 25d
Cleared Jan 22, 1997
RICHARDS TOTAL/PARTIAL PROSTHESIS
K962564 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 205d
Cleared Jan 21, 1997
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
K964639 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 63d
Cleared Jan 17, 1997
APEX UNIVERSAL DRIVE SYSTEM
K964548 · ERL
Linvatec Corp.
Ear, Nose, Throat · 65d
Cleared Jan 17, 1997
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
K964816 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 49d
Cleared Jan 10, 1997
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
K962995 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 162d
Cleared Jan 10, 1997
PORTAREM-3000, PFS-6000
K964340 · EWO
Starkey Laboratories, Inc.
Ear, Nose, Throat · 71d
Cleared Jan 10, 1997
ANSPACH MICROMAX SYSTEM
K965080 · ERL
The Anspach Effort, Inc.
Ear, Nose, Throat · 22d