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
769–792 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 18, 2007
KOREBALANCE (KINESTHETIC ABILITY TRAINER)
K070676 · LXV
Sportkat, LLC
Ear, Nose, Throat · 37d
Cleared Mar 29, 2007
MA 55 MAESTRO
K063452 · EWO
Maico Diagnostics (Diagnostic Group,...
Ear, Nose, Throat · 134d
Cleared Mar 15, 2007
ADVACOAT SINUS GEL AND STENT
K070496 · LYA
Carbylan Biosurgery
Ear, Nose, Throat · 23d
Cleared Mar 07, 2007
OTOGRAM, CA3350
K070118 · EWO
Tympany, Inc.
Ear, Nose, Throat · 54d
Cleared Mar 02, 2007
EARCHECK ACOUSTIC REFLECTOMETER
K070312 · ETY
Innovia Medical, LLC
Ear, Nose, Throat · 29d
Cleared Mar 01, 2007
RADIESSE LARYNGEAL IMPLANT
K070090 · MIX
Bioform Medical, Inc.
Ear, Nose, Throat · 50d
Cleared Feb 26, 2007
BALANCE REHABILITATION UNIT (BRU)
K070085 · LXV
Medicaa (Uruguay) S.A.
Ear, Nose, Throat · 48d
Cleared Jan 24, 2007
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE
K070093 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 14d
Cleared Jan 05, 2007
HILGER DUAL-STIM NERVE STIMULATOR
K063560 · ETN
Wr Medical Electronics Co.
Ear, Nose, Throat · 38d
Cleared Jan 04, 2007
HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
K063338 · EWO
Mimosa Acoustics, Inc.
Ear, Nose, Throat · 59d
Cleared Dec 11, 2006
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE
K062280 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 126d
Cleared Dec 06, 2006
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS...
K063374 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 28d
Cleared Dec 04, 2006
ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200
K063308 · LYA
Carbylan Biosurgery
Ear, Nose, Throat · 32d
Cleared Nov 29, 2006
STIMULATING BUR GUARD
K063305 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 28d
Cleared Oct 24, 2006
GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
K062672 · ETD
Grace Medical, Inc.
Ear, Nose, Throat · 46d
Cleared Oct 24, 2006
MICROENDOSCOPE
K063078 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 14d
Cleared Oct 18, 2006
NASOPORE EAR, MODELS ND04, ND05
K062540 · KCN
Polyganics B.V.,
Ear, Nose, Throat · 49d
Cleared Oct 04, 2006
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND...
K062549 · ETN
Excel Tech. , Ltd.
Ear, Nose, Throat · 35d
Cleared Sep 27, 2006
BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
K062385 · ETD
Grace Medical, Inc.
Ear, Nose, Throat · 43d
Cleared Sep 15, 2006
COCHLEA-SCAN / COCHLEA-SCAN PLUS
K061744 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 86d
Cleared Sep 08, 2006
TRANSEAR BONE CONDUCTION HEARING AID
K062404 · LXB
Ear Technology Corp.
Ear, Nose, Throat · 22d
Cleared Sep 06, 2006
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR...
K061663 · EOB
Rtc Inc.-Memcath Technologies, LLC
Ear, Nose, Throat · 93d
Cleared Aug 31, 2006
EVIS EXERA 180 SYSTEM
K061313 · EOQ
Olympus Medical Systems Corporation
Ear, Nose, Throat · 113d
Cleared Aug 18, 2006
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR...
K061853 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 49d