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
721–744 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Oct 30, 2008
VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)
K082667 · EOB
Visionsense, Ltd.
Ear, Nose, Throat · 48d
Cleared Oct 20, 2008
Y-ADAPTER
K082174 · KTI
Asthmatx, Inc.
Ear, Nose, Throat · 80d
Cleared Oct 02, 2008
STRYKER ESSX WITH NAVIGATION MOUNT
K080052 · ERL
Stryker Corp.
Ear, Nose, Throat · 268d
Cleared Sep 19, 2008
DIZZYFIX
K081602 · LXV
Clearwater Clinical Limited
Ear, Nose, Throat · 105d
Cleared Sep 19, 2008
TYMPANOSTOMY TUBE
K082188 · ETD
Acclarent, Inc.
Ear, Nose, Throat · 46d
Cleared Sep 18, 2008
AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV
K082245 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 42d
Cleared Sep 18, 2008
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
K082569 · EOB
Entellus Medical, Inc.
Ear, Nose, Throat · 13d
Cleared Sep 17, 2008
PRIMADO SURGICAL DRILL
K080722 · ERL
Nakanishi, Inc.
Ear, Nose, Throat · 188d
Cleared Sep 17, 2008
BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25
K081742 · ETN
Baxano, Inc.
Ear, Nose, Throat · 90d
Cleared Sep 05, 2008
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
K081277 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 123d
Cleared Sep 04, 2008
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES,...
K082206 · EWL
Helix Medical, LLC
Ear, Nose, Throat · 30d
Cleared Aug 28, 2008
BAHA INTENSO
K081606 · LXB
Cochlear Americas
Ear, Nose, Throat · 83d
Cleared Aug 26, 2008
STRYKER ESSX MICRODEBRIDER SYSTEM
K073633 · ERL
Stryker Ireland Ltd., Instruments...
Ear, Nose, Throat · 244d
Cleared Jul 18, 2008
AOC SOLUBLE IMPLANT MATERIAL
K081531 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 46d
Cleared Jul 16, 2008
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER
K081841 · ETY
Amplivox, Ltd.
Ear, Nose, Throat · 16d
Cleared Jul 14, 2008
GN OTOMETRICS INSERT EARPHONES
K081234 · EWO
Gn Otometrics
Ear, Nose, Throat · 74d
Cleared Jun 27, 2008
ZEN PROGRAM (MIND 440 HEARING AID)
K080955 · KLW
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 85d
Cleared Jun 27, 2008
MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM
K081542 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 20, 2008
EPLEY OMNIAX
K071973 · LXV
Vesticon
Ear, Nose, Throat · 339d
Cleared May 08, 2008
LYRIC HEARING AID
K081136 · ESD
Insound Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Apr 25, 2008
MODIFICATION TO VF GEL PLUS
K080956 · MIX
Coapt Systems, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 17, 2008
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K080070 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 98d
Cleared Apr 10, 2008
BAHA CORDELLE II
K080363 · MAH
Cochlear Bone Anchored Systems AB
Ear, Nose, Throat · 59d
Cleared Apr 08, 2008
ENTELLUS MEDICAL RS-SERIES SYSTEM
K072302 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 235d