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
505–528 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Feb 19, 2015
Checkpoint, Checkpoint Head & Neck
K150005 · ETN
Ndi Medical, LLC
Ear, Nose, Throat · 48d
Cleared Jan 27, 2015
SCHOELLY SINUSCOPE
K142249 · EOB
Schoelly Fiberoptic GmbH
Ear, Nose, Throat · 166d
Cleared Jan 21, 2015
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored...
K142678 · MAH
Oticon Medical AB
Ear, Nose, Throat · 124d
Cleared Jan 09, 2015
ILLUMINATED MEDIASTINOSCOPE
K141622 · EWY
Aegis Surgical, Ltd.
Ear, Nose, Throat · 206d
Cleared Dec 19, 2014
MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES
K142022 · NLY
Medline Renewal
Ear, Nose, Throat · 147d
Cleared Dec 17, 2014
VIDEO BRONCHOSCOPE SYSTEM
K141366 · EOQ
Scholly Fiberoptic GmbH
Ear, Nose, Throat · 208d
Cleared Nov 26, 2014
Cytosponge Cell Collection Device
K142695 · EOX
Covidien, LLC
Ear, Nose, Throat · 65d
Cleared Nov 21, 2014
STIM PROBE
K133348 · ETN
Spes Medica Srl
Ear, Nose, Throat · 387d
Cleared Oct 23, 2014
HEMOPORE
K141816 · LYA
Polyganics B.V.,
Ear, Nose, Throat · 108d
Cleared Oct 17, 2014
XprESS Multi-Sinus Dilation Tool
K142252 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 64d
Cleared Oct 08, 2014
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER,...
K141456 · PGW
Fiagon GmbH
Ear, Nose, Throat · 128d
Cleared Oct 06, 2014
NOVASHIELD INJECTABLE NASAL PACKING AND STENT
K141704 · LYA
Medtronic, Inc.
Ear, Nose, Throat · 104d
Cleared Sep 26, 2014
PROVOX FREEHANDS FLEXIVOICE
K141380 · EWL
Atos Medical AB
Ear, Nose, Throat · 122d
Cleared Sep 26, 2014
STRYKER S2 DRILL
K141935 · ERL
Stryker Corporation
Ear, Nose, Throat · 71d
Cleared Sep 08, 2014
PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70...
K141551 · PGW
Stryker Corporate
Ear, Nose, Throat · 89d
Cleared Sep 04, 2014
RHINIX NASAL FILTER
K134003 · NUP
Rhinix Aps
Ear, Nose, Throat · 251d
Cleared Aug 22, 2014
PRECEPTIS TYMPANOSTOMY TUBE INSERTER
K133921 · ETD
Preceptis Medical
Ear, Nose, Throat · 242d
Cleared Aug 07, 2014
NASOPORE-FD
K141423 · LYA
Polyganics B.V.,
Ear, Nose, Throat · 69d
Cleared Aug 07, 2014
PATHASSIST LED LIGHT FIBER
K141916 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 23d
Cleared Jul 18, 2014
LEVO TINNITUS MASKING SOFTWARE DEVICE
K140845 · KLW
Otoharmonics Corp
Ear, Nose, Throat · 107d
Cleared Jul 01, 2014
ES2 NEUROMONITORING ACCESSORY INSTRUMENTS
K140400 · ETN
Stryker Corporation
Ear, Nose, Throat · 133d
Cleared Jun 27, 2014
NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER
K140542 · KMA
Rhinosystems, Inc.
Ear, Nose, Throat · 115d
Cleared Jun 19, 2014
PROCEM
K140644 · NEA
Ototronix, LLC
Ear, Nose, Throat · 98d
Cleared Jun 16, 2014
ARTHROCARE NASASTENT CMC NASAL DRESSING
K140992 · LYA
ArthroCare Corporation
Ear, Nose, Throat · 60d