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
529–552 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 10, 2014
SPIROX INEX DEVICE
K132920 · NHB
Spirox, Inc.
Ear, Nose, Throat · 266d
Cleared Jun 09, 2014
ECLERIS SINUSCOPE
K131323 · EOB
Ecleris USA
Ear, Nose, Throat · 397d
Cleared Jun 09, 2014
SENTIERO
K133012 · EWO
Path Medical GmbH
Ear, Nose, Throat · 257d
Cleared May 29, 2014
NIGHT SHIFT
K140190 · MYB
Advanced Brain Monitoring, Inc.
Ear, Nose, Throat · 125d
Cleared Apr 30, 2014
FIAGON NAVIGATION SYSTEM
K133573 · PGW
Fiagon GmbH
Ear, Nose, Throat · 161d
Cleared Apr 25, 2014
ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
K131946 · EOQ
Pentax Medical Company
Ear, Nose, Throat · 302d
Cleared Apr 24, 2014
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K132433 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 262d
Cleared Apr 10, 2014
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
K131028 · EOQ
Pentax Medical Company
Ear, Nose, Throat · 363d
Cleared Apr 09, 2014
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
K132009 · EOB
Schoelly Fiberoptic GmbH
Ear, Nose, Throat · 282d
Cleared Mar 25, 2014
SOLACE SOUND GENERATORS
K132965 · KLW
Amplisound Hearing Products & Services
Ear, Nose, Throat · 186d
Cleared Mar 18, 2014
TINNITUS SOUNDSUPPORT
K133308 · KLW
Oticon A/S
Ear, Nose, Throat · 141d
Cleared Mar 13, 2014
MALLEABLE SUCTION INSTRUMENTS
K133665 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 104d
Cleared Feb 21, 2014
ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
K132039 · EQN
Jedmed Instrument Co.
Ear, Nose, Throat · 234d
Cleared Feb 20, 2014
RELIEVA SCOUT SINUS DILATION SYSTEM
K140160 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 29d
Cleared Feb 12, 2014
HYPERSOUND AUDIO SYSTEM (HSS)
K133352 · EPF
Hypersound Health, Inc.
Ear, Nose, Throat · 104d
Cleared Jan 29, 2014
SPIWAY ENDONASAL ACCESS GUIDE
K132721 · LYA
Spiway, LLC
Ear, Nose, Throat · 152d
Cleared Jan 24, 2014
INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER,...
K133013 · ETY
Inventis S.R.L.
Ear, Nose, Throat · 121d
Cleared Jan 03, 2014
WAVE 2G, SOUL
K130937 · KLW
Hansaton Akustik GmbH
Ear, Nose, Throat · 274d
Cleared Dec 31, 2013
ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
K131053 · ERL
The Anspach Effort, Inc.
Ear, Nose, Throat · 259d
Cleared Dec 31, 2013
NASAL EASE ALLERGY BLOCKER
K132520 · NUP
Hi-Tech Pharmacal, Inc.
Ear, Nose, Throat · 141d
Cleared Dec 23, 2013
LAURIMED POLYPVAC MICRODEBRIDER
K133133 · ERL
Laurimed, LLC
Ear, Nose, Throat · 84d
Cleared Dec 20, 2013
PATHASSIST LIGHT SEEKER
K133563 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 30d
Cleared Dec 17, 2013
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
K130736 · LRC
Helix Medical, LLC
Ear, Nose, Throat · 274d
Cleared Dec 09, 2013
PONTO PLUS AND PONTO PLUS POWER
K132775 · LXB
Oticon Medical AB
Ear, Nose, Throat · 95d