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
217–240 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Feb 04, 2022
VenSure LightGuide
K212774 · LRC
Intersect Ent.
Ear, Nose, Throat · 156d
Cleared Jan 19, 2022
Celeris, Disposable Sinus Debrider
K212650 · ERL
Gyrus Acmi, Inc.
Ear, Nose, Throat · 149d
Cleared Jan 19, 2022
Jabra Enhance Plus
K213424 · QDD
GN Hearing A/S
Ear, Nose, Throat · 90d
Cleared Jan 05, 2022
BHA100 Series Braun Clear Hearing Aid
K212609 · QDD
Kaz USA, Inc., A Helen of Troy Company
Ear, Nose, Throat · 141d
Cleared Dec 29, 2021
Flexible Intubation Video Endoscope – Sterile (FIVE-S)
K212656 · EOQ
Karl Storz Endoscopy America
Ear, Nose, Throat · 128d
Cleared Dec 16, 2021
Ponto 5 SuperPower
K213733 · LXB
Oticon Medical AB
Ear, Nose, Throat · 20d
Cleared Nov 24, 2021
Bronchoscope System
K211169 · EOQ
Shanghai AnQing Medical Instrument...
Ear, Nose, Throat · 219d
Cleared Nov 24, 2021
Trachealator
K211894 · KTI
Disa Medinotec
Ear, Nose, Throat · 156d
Cleared Nov 03, 2021
GlideScope BFlex 2.8 Single-Use Bronchoscope
K211947 · EOQ
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 133d
Cleared Oct 27, 2021
SPIWay Endonasal Access Guide
K213153 · LYA
Spiway, LLC
Ear, Nose, Throat · 29d
Cleared Oct 22, 2021
Neuromark System
K212666 · GEI
Neurent Medical
Ear, Nose, Throat · 60d
Cleared Oct 21, 2021
PENTAX Medical Video Bronchoscope EB11-J10
K210928 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 206d
Cleared Oct 14, 2021
ALGO 7i
K211147 · GWJ
Path Medical GmbH
Ear, Nose, Throat · 178d
Not Cleared Oct 01, 2021
iotaSOFT Insertion System - Drive Unit, Controller and Accessories
DEN190055 · QQH
Iotamotion, Inc.
Ear, Nose, Throat · 653d
Cleared Sep 29, 2021
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha...
K212136 · LXB
Cochlear Americas
Ear, Nose, Throat · 83d
Cleared Aug 26, 2021
Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal...
K212048 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 57d
Cleared Aug 26, 2021
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian...
K212355 · ETN
Checkpoint Surgical
Ear, Nose, Throat · 28d
Cleared Aug 20, 2021
Otoplan
K203486 · QQE
Cascination AG
Ear, Nose, Throat · 266d
Cleared Aug 16, 2021
NuVent Eustachian Tube Dilation Balloon
K210841 · PNZ
Medtronic Xomed, Inc.
Ear, Nose, Throat · 147d
Cleared Aug 10, 2021
Ponto 5 Mini
K211640 · LXB
Oticon Medical AB
Ear, Nose, Throat · 75d
Cleared Aug 09, 2021
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use...
K211030 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 125d
Cleared Jul 28, 2021
Broncho Videoscope System
K210379 · EOQ
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 169d
Cleared Jul 23, 2021
Peregrine Endoscopy System
K202727 · EOB
3nt Medical , Ltd.
Ear, Nose, Throat · 309d
Cleared Jul 19, 2021
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation...
K211291 · PGW
Fiagon GmbH
Ear, Nose, Throat · 82d