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
625–648 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 27, 2012
PATHASSIST LIGHT SEEKER
K113522 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 59d
Cleared Dec 28, 2011
AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
K111618 · EWO
Natus Medical Incorporated
Ear, Nose, Throat · 201d
Cleared Dec 28, 2011
SEASPINE MONOPOLAR PROBE SYSYEM
K111671 · ETN
Seaspine, Inc.
Ear, Nose, Throat · 196d
Cleared Dec 21, 2011
XPRESS MULTI-SINUS DILATION TOOL
K112506 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 113d
Cleared Dec 16, 2011
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
K112733 · EWO
Etymotic Research, Inc.
Ear, Nose, Throat · 87d
Cleared Dec 16, 2011
TINNITUS THERAPY SYSTEM ANM T30 CR
K112752 · KLW
Anm Adaptive Neuromodulation GmbH
Ear, Nose, Throat · 86d
Cleared Nov 18, 2011
OBC BONE ANCHORED HEARING SYSTEM
K112053 · MAH
Oticon Medical AB
Ear, Nose, Throat · 122d
Cleared Nov 03, 2011
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
K110989 · ETN
Neurovision Medical Products, Inc.
Ear, Nose, Throat · 209d
Cleared Oct 27, 2011
OSRAM ITOS
K110326 · ERA
Osram Sylvania, Inc.
Ear, Nose, Throat · 266d
Cleared Oct 21, 2011
E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
K111030 · EOX
Intromedic Co., Ltd.
Ear, Nose, Throat · 191d
Cleared Oct 13, 2011
DISPOSABLE STIMULATING ELECTRODE
K111597 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 127d
Cleared Oct 11, 2011
RELIEVA SPIN SINUS DILATION SYSTEM
K111875 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 102d
Cleared Sep 22, 2011
RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
K112435 · ETN
Rhythmlink International, LLC
Ear, Nose, Throat · 29d
Cleared Sep 15, 2011
PATHASSIST LIGHT FIBER
K111763 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 84d
Cleared Aug 24, 2011
SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
K111293 · KLW
Soundcure, Inc.
Ear, Nose, Throat · 110d
Cleared Aug 22, 2011
RELIEVA SOLO ELITE SINUS BALLOON CATHETER
K111254 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 110d
Cleared Jul 07, 2011
NEURO CHECK DEVICE WITH IO-FLEX WIRE
K110696 · ETN
Baxano, Inc.
Ear, Nose, Throat · 115d
Cleared Jun 28, 2011
DRYTOUCH SUCTION STIMULATOR PROBE
K110712 · ETN
Neurovision Medical Products, Inc.
Ear, Nose, Throat · 106d
Cleared Jun 21, 2011
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
K110831 · LXB
Sonitus Medical, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 15, 2011
PONTO PRO POWER
K103594 · LXB
Oticon Medical AB
Ear, Nose, Throat · 189d
Cleared Jun 14, 2011
ENTELLUS MEDICAL SINUS GUIDEWIRE
K110739 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 89d
Cleared Jun 07, 2011
ILLUMINATING SINUS SEEKER
K110158 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 139d
Cleared May 27, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K110097 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 134d
Cleared May 26, 2011
SURGICAL STIMULATORS
K110422 · ETN
Technomed Europe
Ear, Nose, Throat · 101d