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
25–48 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 08, 2026
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
K260420 · EOQ
MacroLux Medical Technology Co., Ltd.
Ear, Nose, Throat · 58d
Cleared Apr 03, 2026
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717)
K260720 · ETB
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 29d
Cleared Apr 03, 2026
mGRIP Total Prosthesis (3.00 mm) (58689)
K260719 · ETA
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 29d
Cleared Apr 03, 2026
mGRIP Partial Prosthesis (0.75 mm) (58669)
K260718 · ETB
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 29d
Cleared Mar 27, 2026
AVENTIX PFX System (PFX01)
K260255 · GEI
Aventix Medical, Inc.
Ear, Nose, Throat · 58d
Cleared Mar 25, 2026
Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A...
K253184 · EOB
Zhuhai Wesee Meditech Co., Ltd.
Ear, Nose, Throat · 180d
Cleared Mar 20, 2026
Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
K252050 · EOB
Olympus Medical Systems Corporation
Ear, Nose, Throat · 262d
Not Cleared Mar 17, 2026
Tyto Insights for Eardrum Bulging Detection
DEN250014 · SHL
Tyto Care , Ltd.
Ear, Nose, Throat · 330d
Cleared Mar 16, 2026
Stealth AXiS™ ENT clinical application
K253395 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 167d
Cleared Mar 13, 2026
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
K260147 · BTA
Shenzhen Kingboom Technology Co., Ltd.
Ear, Nose, Throat · 52d
Not Cleared Mar 04, 2026
LifeVac
DEN250012 · QXN
Lifevac, LLC
Ear, Nose, Throat · 327d
Cleared Mar 02, 2026
KARL STORZ Mediastinoscopes and Instruments
K260003 · EWY
Karl Storz SE & CO. KG
Ear, Nose, Throat · 59d
Cleared Feb 27, 2026
Evala Nerve Stimulator (EPNR002)
K253536 · ETN
Epineuron Technologies, Inc.
Ear, Nose, Throat · 106d
Cleared Feb 19, 2026
Acclarent AERA Eustachian Tube Balloon Dilation System
K253612 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 93d
Cleared Feb 10, 2026
Earflo (EF001)
K252751 · MJV
Earflo, Inc.
Ear, Nose, Throat · 165d
Cleared Feb 10, 2026
NIM Essence™ EMG Endotracheal Tube (NIMEID060)
K251672 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 256d
Cleared Jan 16, 2026
SeptAlign
K251790 · NHB
Spirair, Inc.
Ear, Nose, Throat · 219d
Cleared Jan 09, 2026
iotaSOFT® Insertion System
K252339 · QQH
Iotamotion, Inc.
Ear, Nose, Throat · 165d
Cleared Dec 12, 2025
FUJIFILM Ultrasonic Endoscope EB-710US
K250863 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 266d
Cleared Dec 05, 2025
KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)
K251731 · EOQ
Karl Storz SE & CO. KG
Ear, Nose, Throat · 182d
Cleared Sep 26, 2025
Tuned Self-Fitting Mobile App
K251208 · SCR
Tuned , Ltd.
Ear, Nose, Throat · 161d
Cleared Sep 23, 2025
Ion Endoluminal System (IF1000)
K252045 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 85d
Cleared Sep 23, 2025
Bipolar applicator CelonProBreath (WB990310)
K252043 · GEI
Olympus Winter & Ibe GmbH
Ear, Nose, Throat · 85d
Cleared Sep 23, 2025
Himaging Bronchscope System
K251894 · EOQ
Himaging Technology (Shanghai) Co., Ltd.
Ear, Nose, Throat · 95d