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
649–672 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared May 23, 2011
OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)
K102199 · LXB
Sophono, Inc.
Ear, Nose, Throat · 292d
Cleared May 18, 2011
VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY,...
K102733 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 238d
Cleared May 10, 2011
BAHA 3 POWER SOUND PROCESSOR
K110996 · LXB
Cochlear Americas
Ear, Nose, Throat · 29d
Cleared May 05, 2011
IE-ZEN (IN CLEAR SERIES HEARING AID)
K110973 · KLW
Widex USA
Ear, Nose, Throat · 29d
Cleared May 03, 2011
TINNITUS SOUND GENERATOR MODULE
K110932 · KLW
Gn Resound A/S
Ear, Nose, Throat · 29d
Cleared Apr 28, 2011
GN OTOMETRICS TYPE 1053 FREEFIT
K110286 · ETW
Gn Otometrics A/S
Ear, Nose, Throat · 87d
Cleared Apr 08, 2011
ACAM 5 AUDIOMETER SYSTEM
K103298 · EWO
Acousticon GmbH
Ear, Nose, Throat · 151d
Cleared Apr 08, 2011
PAIRED HYDROGEL ELECTRODE
K110138 · ETN
Neurovision Medical Products, Inc.
Ear, Nose, Throat · 80d
Cleared Apr 01, 2011
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
K103595 · ETD
Acclarent, Inc.
Ear, Nose, Throat · 114d
Cleared Mar 31, 2011
INSPIRA AIR BALLOON DILATION SYSTEM
K110218 · KTI
Acclarent, Inc.
Ear, Nose, Throat · 65d
Not Cleared Mar 31, 2011
WIDEXLINK IN CLEAR SERIES HEARING AIDS
DEN100025 · OSM
Office Research IN Clinical Amplifiction
Ear, Nose, Throat · 169d
Cleared Feb 23, 2011
CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP...
K103128 · ETN
Cadwell Lab, Inc.
Ear, Nose, Throat · 121d
Cleared Feb 15, 2011
FINESS ENDOSCOPE
K102366 · EOB
Entellus Medical, Inc.
Ear, Nose, Throat · 179d
Cleared Jan 24, 2011
RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS
K102336 · BWH
Boston Scientific Corporation
Ear, Nose, Throat · 159d
Cleared Jan 14, 2011
SOUNDBITE HEARING SYSTEM BY SONITUS
K100649 · LXB
Sonitus Medical, Inc.
Ear, Nose, Throat · 312d
Cleared Jan 06, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K100577 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 311d
Cleared Jan 05, 2011
CERETENE SOLUBLE IMPLANT MATERIAL
K103047 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 82d
Cleared Dec 23, 2010
NYDIAG 200
K102364 · LXV
Interacoustics A/S
Ear, Nose, Throat · 125d
Cleared Dec 22, 2010
EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE
K093715 · KLW
Magnatone Hearing Aid Corp. Dba...
Ear, Nose, Throat · 386d
Cleared Dec 21, 2010
NEUROVISION SE (NERVEANA)
K102862 · ETN
Neurovision Medical Products, Inc.
Ear, Nose, Throat · 82d
Cleared Oct 22, 2010
XPRESS BALLOON DEVICE
K102003 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 99d
Cleared Oct 14, 2010
PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)
K092593 · EWL
Atos Medical AB
Ear, Nose, Throat · 416d
Cleared Sep 24, 2010
NEURALMAS
K100992 · ETN
Innovative Surgical Solutions, LLC...
Ear, Nose, Throat · 168d
Cleared Aug 24, 2010
LARYNGEAL SURFACE ELECTRODE
K093373 · ETN
Spes Medica Srl
Ear, Nose, Throat · 299d