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
697–720 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 22, 2009
EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
K090406 · EWO
Interacoustics AS
Ear, Nose, Throat · 155d
Cleared Jul 20, 2009
STIMULUS/DISSECTION INSTRUMENTS
K090838 · ETN
Axon Systems, Inc.
Ear, Nose, Throat · 115d
Cleared Jul 08, 2009
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
K091681 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 28d
Cleared Jun 17, 2009
COCHLEAR BAHA BP100
K090720 · LXB
Cochlear Bone Anchored Systems AB
Ear, Nose, Throat · 91d
Cleared Jun 12, 2009
AIRWAY BALLOON CATHETER INFLATION DEVICE
K090660 · KTI
Acclarent, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 05, 2009
PROVOX VEGA, MODEL 8130-8135
K090455 · EWL
Atos Medical AB
Ear, Nose, Throat · 102d
Cleared May 22, 2009
DIAGNOSTIC CATHETER SYSTEM
K091250 · EOQ
Cardinal Health, Inc.
Ear, Nose, Throat · 24d
Cleared Apr 09, 2009
TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440...
K083861 · ETY
Interacoustics AS
Ear, Nose, Throat · 106d
Cleared Apr 07, 2009
VERTIGONE BPPV GOGGLE
K082634 · LXV
Vertigone, Inc.
Ear, Nose, Throat · 209d
Cleared Apr 07, 2009
YIELD TISSUE SAMPLER
K090853 · EOQ
Broncus Technologies, Inc.
Ear, Nose, Throat · 8d
Cleared Mar 23, 2009
SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL...
K083780 · ETA
Audio Technologies S.R.L.
Ear, Nose, Throat · 94d
Cleared Mar 20, 2009
OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
K083720 · ERL
Bien-Air Surgery SA
Ear, Nose, Throat · 95d
Cleared Feb 19, 2009
JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
K083488 · KLW
Audifon-USA, Inc.
Ear, Nose, Throat · 86d
Cleared Feb 03, 2009
MEDPOR CUSTOMIZED SURGICAL IMPLANT
K083621 · JOF
Porex Surgical, Inc.
Ear, Nose, Throat · 57d
Cleared Jan 16, 2009
NASO-LARYNGO-PHARYNGOSCOPE
K083553 · EOB
Schoelly Imaging, Inc.
Ear, Nose, Throat · 46d
Cleared Jan 06, 2009
ENTACT SEPTAL STAPLER, MODEL 610-00100
K082750 · OLL
Entrigue Surgical, Inc.
Ear, Nose, Throat · 109d
Cleared Jan 05, 2009
VOCALIS GEL
K081815 · MIX
Cytophil, Inc.
Ear, Nose, Throat · 193d
Cleared Jan 05, 2009
VOCALIS AND VOCALIS SM
K081816 · MIX
Cytophil, Inc.
Ear, Nose, Throat · 193d
Cleared Dec 31, 2008
CLEARVIEW ENDOSCOPE COVER
K080740 · EOB
Invotec International, Inc.
Ear, Nose, Throat · 289d
Cleared Dec 17, 2008
REPROCESSED ENT SHAVERS
K081814 · ERL
Sterilmed, Inc.
Ear, Nose, Throat · 174d
Cleared Dec 09, 2008
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
K080022 · KHJ
Vascular Solutions, Inc.
Ear, Nose, Throat · 341d
Cleared Nov 18, 2008
SYNTHEMED DEVICE
K082276 · LYA
Synthemed, Inc.
Ear, Nose, Throat · 99d
Cleared Nov 14, 2008
OBC BONE ANCHORED HEARING AID SYSTEM
K082108 · LXB
Oticon Medical AB
Ear, Nose, Throat · 112d
Cleared Nov 05, 2008
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
K082720 · EOQ
Olympus Medical Systems Corporation
Ear, Nose, Throat · 49d