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
73–96 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 11, 2025
OTOPLAN
K242120 · QQE
Cascination AG
Ear, Nose, Throat · 266d
Cleared Mar 19, 2025
Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B,...
K250210 · EOQ
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 54d
Cleared Mar 14, 2025
Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope:...
K242010 · EOQ
Shenzhen Sanping Image Technology...
Ear, Nose, Throat · 247d
Cleared Mar 03, 2025
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
K243380 · EOB
Olympus Medical Systems Corporation
Ear, Nose, Throat · 124d
Cleared Feb 14, 2025
ICS Dizcovery (1091)
K242198 · GWN
Natus Medical Denmark Aps
Ear, Nose, Throat · 203d
Cleared Feb 06, 2025
DUTAU-NOVATECH®
K242324 · EOQ
Novatech SA
Ear, Nose, Throat · 184d
Cleared Feb 04, 2025
Geon (S2) Nasal Aspirator
K243138 · BTA
Geon Corporation
Ear, Nose, Throat · 127d
Cleared Jan 31, 2025
Nuance Audio Hearing Aid Software
K243150 · SCR
Luxottica Group S.P.A.
Ear, Nose, Throat · 123d
Cleared Jan 23, 2025
MONARCH™ Platform (MON-000008)
K243219 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 108d
Cleared Jan 17, 2025
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and...
K241142 · ETB
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 267d
Cleared Jan 17, 2025
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial...
K241261 · ETB
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 266d
Cleared Jan 17, 2025
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO...
K241269 · ETA
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 268d
Cleared Jan 16, 2025
Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10,...
K242416 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 154d
Cleared Jan 03, 2025
Synapsys VHIT
K242726 · GWN
Inventis S.R.L.
Ear, Nose, Throat · 115d
Cleared Dec 31, 2024
Nasal Aspirator (NS 13)
K241852 · BTA
Avita Corporation
Ear, Nose, Throat · 187d
Cleared Dec 19, 2024
Integrity V500 (Integrity, Integrity with VEMP)
K242954 · GWJ
Vivosonic, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 18, 2024
FirstFit Surgical Kit
K240763 · EWL
Freudenberg Medical, LLC
Ear, Nose, Throat · 273d
Cleared Dec 13, 2024
Bioscope Neuromonitor Device
K233001 · ETN
Biosys Biyomedikal Muhendislik San....
Ear, Nose, Throat · 448d
Cleared Nov 19, 2024
Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
K242028 · BTA
Dongguanshi Yiyingmei Technology Co.,...
Ear, Nose, Throat · 131d
Cleared Oct 29, 2024
Video Bronchoscope System
K241612 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 146d
Cleared Oct 23, 2024
Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C,...
K240289 · EOQ
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 265d
Cleared Sep 24, 2024
Ion Endoluminal System (IF 1000)
K242070 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 70d
Cleared Sep 19, 2024
MonoStereo
K234096 · EOB
Medicaltek Co., Ltd.
Ear, Nose, Throat · 268d
Not Cleared Sep 12, 2024
Hearing Aid Feature (HAF)
DEN230081 · SCR
Apple, Inc.
Ear, Nose, Throat · 283d