FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,798 results
1393–1416 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Feb 27, 1996
WIDEX MODEL SENSO DIGITAL (C16)
K955879 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 61d
Cleared Feb 27, 1996
EXPANDACELL INJECTO-PAK NASAL PACK
K960228 · EMX
Shippert Medical Technologies Corp.
Ear, Nose, Throat · 41d
Cleared Feb 26, 1996
VENTILATION TUBES
K960477 · ETD
Smith & Nephew, Inc.
Ear, Nose, Throat · 25d
Cleared Feb 22, 1996
SONATA U-01
K955702 · ESD
Electone, Inc.
Ear, Nose, Throat · 69d
Cleared Feb 13, 1996
DYNAMEQ-II OPTION
K955466 · ESD
Qualitone
Ear, Nose, Throat · 75d
Cleared Feb 12, 1996
WIDEX MODEL SENSO DIGITAL (C8)
K955878 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 46d
Cleared Feb 02, 1996
OPTUS OTOSCOPES
K945264 · ERA
Optus, Inc.
Ear, Nose, Throat · 462d
Cleared Feb 02, 1996
HEARING AID IMPRESSION MATERIAL
K955288 · ESD
Crown Delta Corp.
Ear, Nose, Throat · 78d
Cleared Feb 02, 1996
FINETONE FSC,
K955692 · ESD
Finetone Hearing Instruments
Ear, Nose, Throat · 50d
Cleared Feb 02, 1996
RESOUND PERSONAL HEARING SYSTEM BT247
K955867 · ESD
Resound Corp.
Ear, Nose, Throat · 36d
Cleared Jan 30, 1996
TREBAY MICRODEBRIDER SYSTEM
K955704 · EQJ
Trebay Medical Corp.
Ear, Nose, Throat · 46d
Cleared Jan 24, 1996
MIRACLE EAR MIRAGE
K954119 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 145d
Cleared Jan 17, 1996
KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY
K954797 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 91d
Cleared Jan 17, 1996
REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE...
K954922 · ESD
Rexton, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 17, 1996
MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE
K955616 · ETD
Misten Medical Corp.
Ear, Nose, Throat · 37d
Cleared Dec 22, 1995
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH
K942265 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 592d
Cleared Dec 22, 1995
NERVE LOCATOR/MONITOR SYSTEM MODIFICATION
K954601 · ETN
Rln Systems, Inc.
Ear, Nose, Throat · 101d
Cleared Dec 22, 1995
MIRACLE EAR AND AUDIOTONE
K954941 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 53d
Cleared Dec 22, 1995
SOF - ABRASION BUR
K955294 · EQJ
Trebay Medical Corp.
Ear, Nose, Throat · 35d
Cleared Dec 22, 1995
TREBAY SCOPE IRRIGATED CLEARING SLEEVE
K955560 · EOB
Trebay Medical Corp.
Ear, Nose, Throat · 16d
Cleared Dec 22, 1995
RESOUND PERSONAL HEARING SYSTEM BTP W/DAI
K955574 · ESD
Resound Corp.
Ear, Nose, Throat · 15d
Cleared Dec 22, 1995
EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY
K955593 · EMX
Shippert Medical Technologies Corp.
Ear, Nose, Throat · 15d
Cleared Dec 22, 1995
MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K955613 · ETB
Misten Medical Corp.
Ear, Nose, Throat · 11d
Cleared Dec 22, 1995
MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS
K955615 · ETA
Misten Medical Corp.
Ear, Nose, Throat · 11d