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
385–408 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Oct 19, 2017
audifon Tinnitus-Module
K171243 · KLW
Audiofon USA, Inc.
Ear, Nose, Throat · 174d
Cleared Oct 17, 2017
Chitogel Endoscopic Sinus Surgery Kit
K172179 · LYA
Chitogel, Ltd.
Ear, Nose, Throat · 90d
Cleared Sep 27, 2017
Scopis Extended Instrument Set EM
K171661 · PGW
Scopis GmbH
Ear, Nose, Throat · 114d
Cleared Sep 21, 2017
PeriView FLEX
K171232 · KTI
Olympus Surgical Technologies America
Ear, Nose, Throat · 147d
Cleared Sep 15, 2017
Stryker Consolidated Operating Room Equipment (CORE) 2 Console
K171840 · ERL
Stryker Corporation
Ear, Nose, Throat · 87d
Cleared Sep 05, 2017
Relieva SpinPlus Nav Balloon Sinuplasty System
K171687 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 90d
Cleared Aug 29, 2017
Easyscreen
K171506 · EWO
Maico Diagnostics GmbH
Ear, Nose, Throat · 98d
Cleared Aug 25, 2017
ShenDa Sinuscope
K161298 · EOB
Shenyang Shenda Endoscope Co., Ltd.
Ear, Nose, Throat · 473d
Cleared Aug 02, 2017
Hearing Healthcare Pro
K171038 · ETY
Db Diagnostic Systems, Inc.
Ear, Nose, Throat · 118d
Cleared Aug 01, 2017
AED Sinuscope
K170285 · EOB
National Advanced Endoscopy Devices,...
Ear, Nose, Throat · 183d
Cleared Jul 28, 2017
Otowave 302 Portable Tympanometer
K171265 · NAS
Amplivox, Ltd.
Ear, Nose, Throat · 88d
Cleared Jul 14, 2017
Aegis Transit System
K170757 · EWY
Boston-Biomedical Associates
Ear, Nose, Throat · 123d
Cleared Jun 28, 2017
TULA Tube Delivery System
K171239 · ETD
Tusker Medical
Ear, Nose, Throat · 62d
Cleared Jun 23, 2017
CRE Pulmonary Balloon Dilatation Catheter
K170759 · KTI
Boston Scientific Corporation
Ear, Nose, Throat · 102d
Cleared Jun 14, 2017
Alzair Allergy Blocker
K170848 · NUP
Nasaleze International, Ltd.
Ear, Nose, Throat · 85d
Cleared Jun 07, 2017
Cochlear Baha SoundArc
K171088 · LXB
Cochlear Americas
Ear, Nose, Throat · 56d
Cleared May 19, 2017
StealthStationTM S8 ENT Software
K170018 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 136d
Cleared May 17, 2017
TinniLogic Mobile Tinnitus Management Device
K163094 · KLW
Jiangsu Betterlife Medical Co., Ltd.
Ear, Nose, Throat · 194d
Cleared Apr 21, 2017
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
K163537 · EOQ
Covidien, LLC
Ear, Nose, Throat · 126d
Cleared Apr 20, 2017
PENTAX Medical ENT Video Imaging System
K162151 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 261d
Cleared Apr 06, 2017
ViziShot 2 FLEX
K163469 · KTI
Olympus Surgical Technologies America
Ear, Nose, Throat · 115d
Cleared Apr 05, 2017
XprESS ENT Dilation System
K163509 · PNZ
Entellus Medical, Inc.
Ear, Nose, Throat · 111d
Cleared Mar 27, 2017
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K163248 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 129d
Cleared Mar 09, 2017
3.3 mm Laurimed Microdebrider
K163247 · ERL
Laurimed, LLC
Ear, Nose, Throat · 111d