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
817–840 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Sep 21, 2005
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
K052452 · EOB
Olympus Medical Systems Corporation
Ear, Nose, Throat · 15d
Cleared Sep 15, 2005
NUVASIVE NEUROVISION JJB SYSTEM
K051718 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 80d
Cleared Aug 31, 2005
RELIEVA SINUS BALLOON INFLATION DEVICE
K052198 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 19d
Cleared Aug 15, 2005
KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
K051972 · EOX
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 25d
Cleared Jul 11, 2005
SEPRAGEL ENT BIORESORBABLE PACKING/STENT
K043035 · KHJ
Genzyme Corporation
Ear, Nose, Throat · 250d
Cleared Jul 01, 2005
TRANSEAR BONE CONDUCTION HEARING AID
K050653 · LXB
United Hearing Systems, Inc.
Ear, Nose, Throat · 112d
Cleared Jun 03, 2005
REPROCESSED TROCARS
K033591 · KBG
Clearmedical, Inc.
Ear, Nose, Throat · 568d
Cleared May 19, 2005
FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
K050907 · EOQ
Fujinon, Inc.
Ear, Nose, Throat · 38d
Cleared May 16, 2005
DR. THEISS ALERGOL POLLEN BLOCKER CREAM
K042610 · NUP
Dr. Theiss Naturwaren GmbH
Ear, Nose, Throat · 234d
Cleared Apr 29, 2005
REM440
K050496 · ETW
Interacoustics A/S, Assens
Ear, Nose, Throat · 60d
Cleared Apr 29, 2005
VISION-SCIENCES ENT-3000 SCOPE
K050972 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 11d
Cleared Apr 05, 2005
RELIEVA SINUS BALLOON DILATION CATHETER
K043527 · LRC
Exploramed Nc1, Inc.
Ear, Nose, Throat · 105d
Cleared Mar 03, 2005
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
K050162 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 37d
Cleared Feb 10, 2005
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
K050220 · EOQ
Olympus Medical Systems Corporation
Ear, Nose, Throat · 10d
Cleared Feb 04, 2005
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
K043219 · EWO
Interacoustics AS
Ear, Nose, Throat · 74d
Cleared Jan 28, 2005
NEUROMONICS TINNITUS TREATMENT
K043274 · KLW
Neuromonics Pty, Ltd.
Ear, Nose, Throat · 63d
Cleared Jan 24, 2005
FISCH TITANIUM MIDDLE EAR PROSTHESES
K043375 · ETA
Karl Storz Endoscopy
Ear, Nose, Throat · 47d
Cleared Dec 23, 2004
EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
K043090 · LZI
Phonic Ear, Inc.
Ear, Nose, Throat · 45d
Cleared Nov 22, 2004
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
K043138 · EWL
Atos Medical AB
Ear, Nose, Throat · 10d
Cleared Nov 08, 2004
OTOMIMIX
K042516 · NEA
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 53d
Cleared Oct 01, 2004
KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
K042503 · ETA
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 16d
Cleared Sep 10, 2004
CHIN-UP STRIP
K040491 · LWF
Dale Miller, Inc. - the Chin-Up Company
Ear, Nose, Throat · 197d
Cleared Sep 10, 2004
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K041381 · LYA
Medtronic Xomed, Inc.
Ear, Nose, Throat · 108d
Cleared Sep 03, 2004
OTOGRAM
K041853 · ETW
Tympany, Inc.
Ear, Nose, Throat · 57d