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
673–696 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 13, 2010
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
K100360 · LXB
Cochlear Americas
Ear, Nose, Throat · 151d
Cleared May 18, 2010
OTOMAG BONE CONDUCTION HEARING SYSTEM
K100193 · LXB
Sophono, Inc.
Ear, Nose, Throat · 116d
Cleared May 11, 2010
ZZOMA POSITIONAL SLEEPER MODEL 001
K100160 · MYB
Sleep Specialists, LLC
Ear, Nose, Throat · 111d
Cleared Mar 10, 2010
CLARUJUST
K092089 · EWO
Audigence, Inc.
Ear, Nose, Throat · 244d
Cleared Mar 03, 2010
BLOM-SINGER INDWELLING TEP OCCLUDER
K093258 · EWL
Helix Medical, LLC
Ear, Nose, Throat · 135d
Cleared Mar 01, 2010
MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS
K092244 · EWO
Diagnostic Group, LLC
Ear, Nose, Throat · 216d
Cleared Feb 25, 2010
VISION SCIENCES FLEXIBLE ENT SCOPE
K100125 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 37d
Cleared Feb 17, 2010
PDS PLATES
K092590 · NHB
Ethicon, Inc.
Ear, Nose, Throat · 177d
Cleared Feb 05, 2010
ENTELLUS MEDICAL BALLOON DEVICE
K093007 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 130d
Cleared Dec 30, 2009
FONIX ,MODEL 8000
K093006 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 93d
Cleared Nov 18, 2009
INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656
K091874 · ETN
Inomed Medizintechnik GmbH
Ear, Nose, Throat · 148d
Cleared Nov 17, 2009
SINEXUS SINUS STENT GEN 2, MODEL 1999-25
K092401 · LYA
Sinexus, Inc.
Ear, Nose, Throat · 103d
Cleared Oct 28, 2009
CHECKPOINT
K092292 · ETN
Ndi Medical, LLC
Ear, Nose, Throat · 91d
Cleared Oct 02, 2009
ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC...
K092111 · EWO
Entomed AB
Ear, Nose, Throat · 80d
Cleared Oct 02, 2009
BAXANO NEURO CHECK DEVICE
K092729 · ETN
Baxano, Inc.
Ear, Nose, Throat · 28d
Cleared Sep 14, 2009
RUTTER SUPRA STOMAL STENTS
K091135 · FWN
Boston Medical Products, Inc.
Ear, Nose, Throat · 147d
Cleared Sep 14, 2009
GRACE DYNAMIC TORP
K091187 · ETA
Grace Medical, Inc.
Ear, Nose, Throat · 144d
Cleared Sep 11, 2009
VF LIQUIGEL
K083783 · MIX
Coapt Systems, Inc.
Ear, Nose, Throat · 266d
Cleared Aug 20, 2009
LSVT C OR LSVT COMPANION, MODEL V.1
K091682 · LEZ
Lsvt Global, LLC
Ear, Nose, Throat · 71d
Cleared Aug 12, 2009
SWITCH TRT
K091552 · KLW
Audifon GmbH & Co. KG
Ear, Nose, Throat · 77d
Cleared Aug 06, 2009
I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO...
K083603 · GWN
Neuro Kinetics
Ear, Nose, Throat · 244d
Cleared Aug 03, 2009
VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM,...
K091768 · EOQ
Vision-Sciences, Inc.
Ear, Nose, Throat · 48d
Cleared Jul 29, 2009
NEUROSIGN AVALANCHE MOTOR NERVE MONITOR
K083242 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 268d
Cleared Jul 29, 2009
PONTO PRO
K090996 · LXB
Oticon Medical AB
Ear, Nose, Throat · 112d