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
145–168 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 03, 2023
ATMOS Scope (507.7000.0)
K232015 · EOB
Atmos Medizintechnik GmbH & Co. KG
Ear, Nose, Throat · 28d
Cleared Jul 28, 2023
PatCom Distal Chip Endoscope
K222587 · EOB
H&A Mui Enterprises, Inc.
Ear, Nose, Throat · 336d
Cleared Jul 21, 2023
TruDi® Navigation System V3 (FG-2000-00)
K231862 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 28d
Not Cleared Jul 19, 2023
Galen ES Cooperative Surgical Assistant Platform, Galen ES
DEN220047 · QXG
Galen Robotics
Ear, Nose, Throat · 362d
Cleared Jun 30, 2023
Tinearity G1 (6103)
K223694 · KLW
Duearity AB
Ear, Nose, Throat · 203d
Cleared Jun 29, 2023
NeuroSwift Pro
K223047 · GWN
Neurobit Technologies Co., Ltd.
Ear, Nose, Throat · 273d
Cleared Jun 16, 2023
All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
K230538 · QUH
Sonova AG
Ear, Nose, Throat · 109d
Cleared Jun 15, 2023
EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus...
K222861 · EOQ
Olympus Medical Systems Corporation
Ear, Nose, Throat · 266d
Cleared Jun 14, 2023
Single-use Flexible Rhinolaryngoscope
K230536 · EOB
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 107d
Cleared Jun 09, 2023
Ear Pressure Relief Device(Model:ER813B)
K230502 · MJV
Ningbo Albert Novosino Co., Ltd.
Ear, Nose, Throat · 105d
Cleared Jun 01, 2023
Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu®...
K223299 · EOQ
Ambu A/S
Ear, Nose, Throat · 217d
Cleared May 26, 2023
VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System,...
K230065 · PNZ
Fiagon GmbH
Ear, Nose, Throat · 137d
Cleared May 25, 2023
BB 8 Sinus Dilation Kit
K230258 · LRC
Excelent, Inc.
Ear, Nose, Throat · 114d
Cleared May 15, 2023
Vathin® Video Bronchoscope System
K223836 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 144d
Cleared May 11, 2023
ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
K230280 · KTI
Ga Health Company Limited
Ear, Nose, Throat · 99d
Cleared May 03, 2023
BFlex™ 2 Slim 3.8 Single-Use Bronchoscope
K230948 · EOQ
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 29d
Cleared Apr 27, 2023
ENT EM
K223734 · PGW
Brainlab AG
Ear, Nose, Throat · 135d
Cleared Apr 11, 2023
Bronchoscope System
K222910 · EOQ
Shenzhen HugeMed Medical Technical...
Ear, Nose, Throat · 197d
Cleared Mar 22, 2023
Epi-Stop Nasal Gel/epistaxis pack
K230142 · LYA
Biomed Ent, Inc.
Ear, Nose, Throat · 63d
Cleared Mar 14, 2023
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
K223137 · QUH
Hearx SA (Pty) , Ltd.
Ear, Nose, Throat · 161d
Not Cleared Mar 06, 2023
Lenire Tinnitus Treatment Device
DEN210033 · QVN
Neuromod Devices Limited
Ear, Nose, Throat · 565d
Cleared Mar 01, 2023
Multistage Balloon Dilatation Catheter
K222187 · KTI
Dongguan TT Medical, Inc.
Ear, Nose, Throat · 222d
Cleared Mar 01, 2023
Galaxy System
K223144 · EOQ
Noah Medical Corp.
Ear, Nose, Throat · 148d
Cleared Feb 02, 2023
Geonic Nasal Aspirator, Geonic Nasal Cleaner
K220126 · BTA
Geon Corporation
Ear, Nose, Throat · 380d