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
361–384 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 27, 2018
ADHEAR System
K172460 · LXB
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 256d
Cleared Apr 26, 2018
LungVision Tool
K172955 · EOQ
Bodyvision Medical , Ltd.
Ear, Nose, Throat · 212d
Cleared Apr 20, 2018
Sharpsite AC Rigid Endsocope
K173855 · EOB
Medtronic Xomed, Inc.
Ear, Nose, Throat · 121d
Cleared Apr 13, 2018
Reza Band, Reflux Band
K173934 · PKA
Somna Therapeutics, LLC
Ear, Nose, Throat · 108d
Cleared Apr 05, 2018
PENTAX Medical EPK-3000 Video Imaging System
K172156 · EOB
Pentax Medical
Ear, Nose, Throat · 261d
Cleared Apr 02, 2018
K-D Balance
K173669 · LXV
King-Devick Technologies, Inc.
Ear, Nose, Throat · 123d
Cleared Mar 28, 2018
Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2
K173727 · EOQ
Ambu A/S
Ear, Nose, Throat · 113d
Cleared Mar 27, 2018
OCM-G1 Attachment
K180063 · ERL
The Anspach Effort, Inc.
Ear, Nose, Throat · 77d
Cleared Mar 22, 2018
Monarch Endoscopy Platform (Monarch Platform)
K173760 · EOQ
Auris Surgical Robotics, Inc.
Ear, Nose, Throat · 101d
Cleared Mar 10, 2018
Acclarent ENT Navigation System
K173628 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 106d
Cleared Feb 21, 2018
Captura Disposable Bronchoscope Biopsy Forceps
K163377 · EOQ
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 447d
Cleared Feb 16, 2018
SPIWay Endonasal Access Guide
K180141 · LYA
Spiway, LLC
Ear, Nose, Throat · 29d
Cleared Feb 14, 2018
Sera
K173567 · EWO
Interacoustics A/S
Ear, Nose, Throat · 86d
Cleared Feb 02, 2018
KARL STORZ Slim Nasopharyngolaryngoscope
K171402 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 266d
Cleared Jan 19, 2018
FUJIFILM Bronchoscope Model EB-530P
K171291 · EOQ
Fujifilm Medical Systems U.S.A, Inc.
Ear, Nose, Throat · 262d
Cleared Jan 19, 2018
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video...
K173554 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 63d
Cleared Jan 16, 2018
ACCLARENT AERA Eustachian Tube Balloon Dilation System
K171761 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 216d
Cleared Dec 27, 2017
PoreStar Patient Specific Implant
K171037 · JOF
Anatomics Pty, Ltd.
Ear, Nose, Throat · 265d
Cleared Dec 15, 2017
Composite Removable Sinus Stent System
K170913 · LYA
Sts Medical
Ear, Nose, Throat · 262d
Cleared Dec 12, 2017
MESIRE - Balloon Sinus Dilatation System
K172737 · LRC
M/S. Meril Life Sciences Private Limited
Ear, Nose, Throat · 92d
Cleared Nov 22, 2017
I-Portal Portable Assessment System - Nystagmograph (I-PAS)
K171884 · GWN
Neuro Kinetics, Inc.
Ear, Nose, Throat · 152d
Cleared Nov 20, 2017
B7 2C Occlusion Balloon
K171492 · EOQ
Spiration, Inc.
Ear, Nose, Throat · 182d
Cleared Oct 20, 2017
GSI Novus
K172403 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 72d
Cleared Oct 19, 2017
Medrobotics Flex Robotic System
K170453 · EOB
Medrobotics Corporation
Ear, Nose, Throat · 246d