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
433–456 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 29, 2016
Vent-Os Sinus Dilation family
K160770 · LRC
Sinusys Corporation
Ear, Nose, Throat · 100d
Cleared Jun 23, 2016
Latera Absorbable Nasal Implant
K161191 · NHB
Spirox, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 22, 2016
PolypVac Microdebrider (3.3mm and 4.0mm)
K161101 · ERL
Laurimed, LLC
Ear, Nose, Throat · 64d
Cleared Jun 16, 2016
Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
K153391 · LXB
Sophono, Inc.
Ear, Nose, Throat · 205d
Cleared Jun 10, 2016
DIEGO ELITE DRILL
K152744 · ERL
Gyrus Acmi, Inc.
Ear, Nose, Throat · 261d
Cleared May 26, 2016
Auris Robotic Endoscopy System (ARES)
K152319 · EOQ
Auris Surgical Robotics, Inc.
Ear, Nose, Throat · 283d
Cleared May 20, 2016
Baha 5 Power Sound Processor
K161123 · LXB
Cochlear Americas
Ear, Nose, Throat · 29d
Cleared May 19, 2016
Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
K152466 · EOQ
Prosurg, Inc.
Ear, Nose, Throat · 262d
Cleared May 11, 2016
Biodesign Otologic Repair Graft
K161000 · KHJ
Cook Biotech Incorporated
Ear, Nose, Throat · 30d
Cleared May 06, 2016
FREMAP ELECTRODE
K152769 · ETN
Ad-Tech Medical Instrument Corporation
Ear, Nose, Throat · 224d
Cleared Apr 12, 2016
Cytosponge Cell Collection Device
K152794 · EOX
Covidien, LLC
Ear, Nose, Throat · 197d
Cleared Apr 07, 2016
EM ENT Navigated Suctions
K153555 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 115d
Cleared Apr 06, 2016
Wireless Earlens Light Driven Hearing Aid
K153634 · PLK
Earlens Corporation
Ear, Nose, Throat · 110d
Cleared Apr 05, 2016
ULTRA Telescopes
K153009 · EOB
Olympus Winter & Ibe GmbH
Ear, Nose, Throat · 174d
Cleared Mar 23, 2016
PointerShell Universal, PointerShell LS
K160479 · PGW
Fiagon GmbH
Ear, Nose, Throat · 30d
Cleared Mar 10, 2016
GuideWire
K160369 · PGW
Fiagon GmbH
Ear, Nose, Throat · 29d
Cleared Mar 02, 2016
Baha 5 Super Power Sound Processor
K153245 · LXB
Cochlear Americas
Ear, Nose, Throat · 114d
Cleared Feb 26, 2016
Illuminated Mediastinal Access Port
K160171 · EWY
Aegis Surgical, Ltd.
Ear, Nose, Throat · 30d
Cleared Feb 19, 2016
ViziShot FLEX
K152922 · KTI
Spiration, Inc.
Ear, Nose, Throat · 140d
Cleared Feb 18, 2016
Fusion Compact Navigation System
K153247 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 101d
Cleared Feb 12, 2016
Relieva Scout Multi-Sinus Dilation System
K153341 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 85d
Cleared Feb 01, 2016
C2 NerveMonitor System
K152505 · ETN
Inomed Medizintechnik GmbH
Ear, Nose, Throat · 152d
Cleared Jan 28, 2016
SPIWay Endonasal Access Guide
K153686 · LYA
Spiway, LLC
Ear, Nose, Throat · 36d
Cleared Jan 22, 2016
Ponto Bone Anchored Hearing System
K152820 · MAH
Oticon Medical AB
Ear, Nose, Throat · 116d