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
457–480 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 20, 2016
Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System
K151558 · KLW
Neurotherapies Reset GmbH
Ear, Nose, Throat · 224d
Cleared Jan 15, 2016
InstaClear Lens Cleaner
K152531 · EOB
Gyrus Acmi, Inc.
Ear, Nose, Throat · 134d
Cleared Jan 08, 2016
Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver...
K150969 · ERL
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 270d
Cleared Dec 29, 2015
iHearTest
K151025 · EWO
Ihear Medical, Inc.
Ear, Nose, Throat · 257d
Cleared Dec 04, 2015
INEX Absorbable Nasal Implant
K152958 · NHB
Spirox, Inc.
Ear, Nose, Throat · 58d
Cleared Dec 01, 2015
NuVent EM Sinus Dilation System
K152121 · LRC
Medtronic Xomed, Inc.
Ear, Nose, Throat · 124d
Cleared Nov 23, 2015
Ponto bone anchored hearing system
K152067 · MAH
Oticon Medical AB
Ear, Nose, Throat · 122d
Cleared Nov 20, 2015
XprESS Multi-Sinus Dilation System
K152434 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 85d
Cleared Nov 20, 2015
PassAssist LED Light Fiber
K152435 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 85d
Cleared Nov 20, 2015
Pi Drive Plus Motor, Extender
K152641 · ERL
Stryker Corporation
Ear, Nose, Throat · 66d
Cleared Nov 10, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151315 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 176d
Cleared Oct 29, 2015
PENTAX Medical EKP-i5010 Video Processor with EB Family
K143727 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 304d
Cleared Oct 09, 2015
REVE134
K151719 · KLW
Kw Ear Lab, Inc.
Ear, Nose, Throat · 106d
Not Cleared Sep 29, 2015
EarLens Contact Hearing Device
DEN150002 · PLK
Earlens Corporation
Ear, Nose, Throat · 270d
Cleared Sep 21, 2015
Hummingbird Tympanostomy Tube
K151830 · ETD
Preceptis Medical
Ear, Nose, Throat · 77d
Cleared Sep 17, 2015
DEFENDO Bronchoscopy Suction Valve
K151522 · KTI
Medivators, Inc.
Ear, Nose, Throat · 104d
Cleared Sep 16, 2015
Biodesign Otologic Repair Graft
K150594 · KHJ
Cook Biotech Incorprated
Ear, Nose, Throat · 191d
Cleared Aug 27, 2015
DSS Sinusplasty Balloon Catheter
K143738 · LRC
Intuit Medical Products, LLC
Ear, Nose, Throat · 240d
Cleared Aug 14, 2015
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
K150728 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 147d
Cleared Jul 27, 2015
Serenity
K150014 · KLW
Sanuthera, Inc.
Ear, Nose, Throat · 203d
Cleared Jul 23, 2015
ORL Video NasoPharyngo-Larngoscope
K150248 · EQN
Jedmed Instrument Company
Ear, Nose, Throat · 170d
Cleared Jul 22, 2015
Cordelle II Sound Processor
K150751 · LXB
Cochlear Americas
Ear, Nose, Throat · 121d
Cleared Jul 22, 2015
Ventilation (Tympanostomy) Tubes
K151067 · ETD
Medtronic Xomed, Inc.
Ear, Nose, Throat · 92d
Cleared Jul 17, 2015
Medrobotics Flex System
K150776 · EOB
Medrobotics Corporation
Ear, Nose, Throat · 115d