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
193–216 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 03, 2022
QScreen
K220139 · GWJ
Path Medical GmbH
Ear, Nose, Throat · 197d
Cleared Jul 29, 2022
RhinAer® Stylus (FG1393)
K221907 · GEI
Aerin Medical, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 28, 2022
EXALT Model B Single-Use Bronchoscope
K222014 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 20d
Cleared Jul 27, 2022
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound...
K220922 · PFO
Cochlear Americas
Ear, Nose, Throat · 118d
Cleared Jul 27, 2022
Hummingbird Tympanostomy Tube System
K221254 · ETD
Preceptis Medical, Inc.
Ear, Nose, Throat · 86d
Cleared Jul 25, 2022
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
K220606 · EOQ
Ambu A/S
Ear, Nose, Throat · 145d
Cleared Jul 20, 2022
TruDi Shaver Blade
K221037 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 104d
Cleared Jul 12, 2022
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software,...
K221098 · PGW
Stryker Corporation
Ear, Nose, Throat · 89d
Cleared Jul 08, 2022
Single-Use Video Bronchoscopes, Digital Controller
K213782 · EOQ
Micro-Tech (Nanjing) Co., Lts
Ear, Nose, Throat · 217d
Cleared Jul 01, 2022
ENT Nasopharyngoscope and Accessories
K214050 · EOB
Medimaging Integrated Solution, Inc...
Ear, Nose, Throat · 186d
Cleared Jun 24, 2022
BentrioTM Allergy Blocker
K213114 · NUP
Altamira Therapeutics, Inc.
Ear, Nose, Throat · 270d
Cleared Jun 24, 2022
OTOPLAN
K220300 · QQE
Cascination AG
Ear, Nose, Throat · 142d
Cleared Jun 23, 2022
HD Mediastinoscope
K213194 · EWY
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 267d
Cleared Jun 22, 2022
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced,...
K213345 · EWO
Path Medical GmbH
Ear, Nose, Throat · 257d
Cleared Jun 16, 2022
Ion Endoluminal System (IF1000)
K220299 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 134d
Cleared Jun 16, 2022
WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible...
K220399 · EOQ
OTU Medical, Inc.
Ear, Nose, Throat · 125d
Cleared Jun 14, 2022
Zsquare ENT-Flex Endoscope
K220004 · EOB
Zsquare, Ltd.
Ear, Nose, Throat · 161d
Cleared May 05, 2022
PosiSep EAR Fragmentable Ear Dressing
K210411 · NHB
Hemostasis, LLC
Ear, Nose, Throat · 448d
Cleared Apr 27, 2022
GyroStim
K220231 · LXV
Ultrathera Technologies, Inc.
Ear, Nose, Throat · 90d
Cleared Apr 12, 2022
Audion ET dilation system
K220027 · PNZ
Entellus Medical, Inc.
Ear, Nose, Throat · 97d
Cleared Mar 21, 2022
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball...
K213246 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 172d
Cleared Mar 08, 2022
Elation Pulmonary Balloon Dilation Catheter
K213434 · KTI
Merit Medical Systems, Inc.
Ear, Nose, Throat · 137d
Cleared Feb 28, 2022
Vathin Video Bronchoscope System
K213635 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 103d
Cleared Feb 16, 2022
Broncoflex Agile, Broncoflex Vortex, Screeni
K212886 · EOQ
Axess Vision Technology
Ear, Nose, Throat · 159d