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
577–600 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared May 17, 2013
AIO HD OTOSCOPE
K123821 · ERA
Blue Focus
Ear, Nose, Throat · 156d
Cleared May 07, 2013
UNITRON TINNITUS MASKER FEATURE
K130494 · KLW
Unitron Hearing
Ear, Nose, Throat · 70d
Cleared Apr 08, 2013
OTOMAG BONE CONDUCTION HEARING SYSTEM
K123962 · LXB
Sophono, Inc.
Ear, Nose, Throat · 103d
Cleared Mar 28, 2013
OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
K123624 · EWO
Mimosa Acoustics, Inc.
Ear, Nose, Throat · 125d
Cleared Mar 27, 2013
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
K122494 · LYA
Hemostasis, LLC
Ear, Nose, Throat · 223d
Cleared Feb 27, 2013
BIODESIGN ENT REPAIR GRAFT
K121360 · KHJ
Cook Biotech Incorprated
Ear, Nose, Throat · 296d
Cleared Feb 22, 2013
CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
K121795 · MIX
Cytophil, Inc.
Ear, Nose, Throat · 248d
Cleared Feb 11, 2013
PHONAK TINNITUS BALANCE
K123450 · KLW
Phonak, LLC
Ear, Nose, Throat · 94d
Cleared Feb 08, 2013
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
K112616 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 519d
Cleared Jan 25, 2013
LANTOS 3D EAR SCANNER
K121326 · ERA
Lantos Technologies
Ear, Nose, Throat · 268d
Cleared Jan 10, 2013
EVIS EXERA III VIDEO SYSTEM
K121959 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 189d
Cleared Dec 13, 2012
FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
K122535 · EOQ
Fujifilm Medical System U.S.A., Inc.
Ear, Nose, Throat · 115d
Cleared Nov 29, 2012
TITAN
K121847 · ETY
Interacoustics A/S
Ear, Nose, Throat · 157d
Cleared Nov 27, 2012
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
K122561 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 97d
Cleared Nov 05, 2012
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
K120280 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 280d
Cleared Nov 01, 2012
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
K121793 · LXB
Audifon-USA, Inc.
Ear, Nose, Throat · 135d
Cleared Nov 01, 2012
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K122496 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 77d
Cleared Oct 31, 2012
MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
K122434 · NHB
Medtronic Xomed
Ear, Nose, Throat · 82d
Cleared Oct 31, 2012
MULTIFLEX TINNITUS TECHNOLOGY
K122876 · KLW
Starkey Laboratories
Ear, Nose, Throat · 42d
Cleared Oct 23, 2012
AURICAL HIT
K122028 · ETW
Gn Otometrics
Ear, Nose, Throat · 105d
Cleared Oct 19, 2012
NONDISPOSABLE STIMULATING INSTRUMENTS
K121931 · ETN
Neurovision Medical Products, Inc.
Ear, Nose, Throat · 109d
Cleared Oct 12, 2012
COCHLEAR BAHA IMPLANT SYSTEM
K121317 · MAH
Cochlear Americas
Ear, Nose, Throat · 163d
Cleared Sep 20, 2012
VESTIBULAR ANALYSIS APPARATUS
K121590 · LXV
Capacity Sports, LLC
Ear, Nose, Throat · 112d
Cleared Sep 07, 2012
PONTO BONE ANCHORED HEARING SYSTEM
K121228 · MAH
Oticon Medical AB
Ear, Nose, Throat · 137d