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
409–432 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Mar 02, 2017
TIPCAM 1S 3D System
K162410 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 185d
Cleared Feb 24, 2017
3NT endoscopy system
K162916 · EOB
3nt Medical , Ltd.
Ear, Nose, Throat · 130d
Cleared Feb 16, 2017
Fiagon Navigation – PointerTube Straight and PointerTube Keat
K163416 · PGW
Fiagon GmbH
Ear, Nose, Throat · 73d
Cleared Feb 09, 2017
Scopis Hybrid Navigation System EM
K161491 · PGW
Scopis GmbH
Ear, Nose, Throat · 253d
Cleared Feb 09, 2017
PeriFLEX
K162611 · EOQ
Spiration, Inc.
Ear, Nose, Throat · 143d
Cleared Jan 17, 2017
Precision Thin Reciprocating Blade, 0.010in.
K161514 · EQJ
Stryker Corporation
Ear, Nose, Throat · 229d
Cleared Dec 01, 2016
Fiagon Navigation System
K162176 · PGW
Fiagon GmbH
Ear, Nose, Throat · 120d
Cleared Nov 16, 2016
touchTymp
K162210 · ETY
Maico Diagnostics GmbH
Ear, Nose, Throat · 103d
Cleared Oct 24, 2016
Acclarent NavWire Sinus Navigation Guidewire
K161697 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 126d
Cleared Oct 24, 2016
Relieva UltirraNav Sinus Balloon Catheter
K161698 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 126d
Cleared Oct 24, 2016
CARTO ENT System
K161701 · PGW
Biosense Webster
Ear, Nose, Throat · 126d
Cleared Oct 21, 2016
KARL STORZ NAV1 Electromagnetic Navigation System
K161555 · PGW
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 137d
Cleared Sep 29, 2016
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
K161671 · LXB
Oticon Medical AB
Ear, Nose, Throat · 105d
Cleared Sep 28, 2016
Sound Options Tinnitus Treatment
K161562 · KLW
Sound Options Tinnitus Treatments, Inc.
Ear, Nose, Throat · 114d
Cleared Sep 18, 2016
Guidewire 0.6 Single Use
K161940 · PGW
Fiagon GmbH
Ear, Nose, Throat · 66d
Not Cleared Sep 16, 2016
Acclarent Aera Eustachian Tube Balloon Dilation System
DEN150056 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 284d
Cleared Sep 09, 2016
ULYSS Multi View Sinuscope
K153701 · EOB
Sopro-Comeg GmbH
Ear, Nose, Throat · 261d
Cleared Sep 01, 2016
Elation Pulmonary Balloon Dilation
K161392 · KTI
Merit Medical Systems, Inc.
Ear, Nose, Throat · 105d
Cleared Sep 01, 2016
Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3...
K161656 · EOQ
Ambu A/S
Ear, Nose, Throat · 77d
Cleared Sep 01, 2016
Madsen Zodiac
K161707 · ETY
Gn Otometrics
Ear, Nose, Throat · 72d
Cleared Aug 25, 2016
DragonFly Surgical Drill System
K161376 · ERL
Grace Medical, Inc.
Ear, Nose, Throat · 99d
Cleared Aug 23, 2016
HyperSound Tinnitus Module
K161331 · KLW
Turtle Beach Corporation
Ear, Nose, Throat · 103d
Cleared Jul 27, 2016
Dillard Airway Dilatation System
K153484 · KTI
Intuit Medical Products, LLC
Ear, Nose, Throat · 237d
Cleared Jul 27, 2016
SinuBand
K160101 · QJL
Bioinspire Technologies, Incorporated
Ear, Nose, Throat · 190d