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
481–504 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 15, 2015
BA400 14mm Abutment
K150555 · MAH
Cochlear Americas
Ear, Nose, Throat · 133d
Cleared Jul 15, 2015
AT235
K151616 · ETY
Interacoustics A/S
Ear, Nose, Throat · 30d
Cleared Jul 08, 2015
I-Portal NOTC, VNG and VOG
K143607 · GWN
Neuro Kinetics, Inc.
Ear, Nose, Throat · 201d
Cleared Jun 25, 2015
aeris Balloon Dialation Catheter
K150951 · KTI
Bryan Medical, Inc.
Ear, Nose, Throat · 77d
Cleared Jun 25, 2015
GSI TympStar Pro Middle Ear Analyzer
K151509 · ETY
Diagnostic Group, Dba Grason-Stadler
Ear, Nose, Throat · 21d
Cleared Jun 17, 2015
CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial...
K142934 · EOQ
Covidien
Ear, Nose, Throat · 251d
Cleared Jun 11, 2015
PulmoVia Working Channel
K150280 · EOQ
Sanovas, Inc.
Ear, Nose, Throat · 126d
Cleared May 14, 2015
Tinnitus Sound Generator Module
K150171 · KLW
Gn Resound A/S
Ear, Nose, Throat · 108d
Cleared Apr 29, 2015
GenCut Core Biopsy System
K142839 · EOQ
Covidien, LLC
Ear, Nose, Throat · 211d
Cleared Apr 24, 2015
Flexible 19G EBUS Needle
K142909 · EOQ
Spiration, Inc.
Ear, Nose, Throat · 200d
Cleared Apr 23, 2015
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)
K142282 · ETD
Preceptis Medical
Ear, Nose, Throat · 251d
Cleared Apr 23, 2015
Otowave 202 Portable Tympanometer
K150163 · NAS
Amplivox, Ltd.
Ear, Nose, Throat · 87d
Cleared Apr 22, 2015
Relieva SpinPlus Balloon Sinuplasty System
K143541 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 128d
Cleared Apr 16, 2015
FlexPointer 1.5 mm
K150473 · PGW
Fiagon GmbH
Ear, Nose, Throat · 52d
Cleared Apr 13, 2015
SoundCure Serenade Tinnitus Treatment System
K150065 · KLW
Soundcure, Inc.
Ear, Nose, Throat · 90d
Cleared Apr 07, 2015
ACCLARENT SE Inflation Device
K150172 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 71d
Cleared Apr 06, 2015
Renu Gel
K150400 · MIX
Cytophil, Inc.
Ear, Nose, Throat · 47d
Cleared Mar 26, 2015
ER36 Series OAE Test System
K150491 · EWO
Etymotic Research, Inc.
Ear, Nose, Throat · 29d
Cleared Mar 25, 2015
Baha 5 Sound Processor
K142907 · LXB
Cochlear Americas
Ear, Nose, Throat · 170d
Cleared Mar 12, 2015
NEURO-AUDIO
K141524 · EWO
Teleemg, LLC USA
Ear, Nose, Throat · 276d
Not Cleared Mar 06, 2015
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
DEN130046 · PKA
Somna Therapeutics, LLC
Ear, Nose, Throat · 477d
Cleared Mar 04, 2015
OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control...
K143492 · ERL
Bien-Air Surgery SA
Ear, Nose, Throat · 86d
Cleared Mar 04, 2015
CMOS Video Nasopharyngoscope System
K143673 · EOB
Schoelly Fiberoptic GmbH
Ear, Nose, Throat · 70d
Cleared Feb 23, 2015
Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR...
K143395 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 89d