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
1417–1440 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Dec 21, 1995
OPTUS BRONCHOSCOPES
K945268 · EOQ
Optus, Inc.
Ear, Nose, Throat · 419d
Cleared Dec 21, 1995
OTOSCAPE
K953814 · EWO
Soundscape Technologies, Inc.
Ear, Nose, Throat · 129d
Cleared Dec 21, 1995
EASY BREATHING NASAL STRIPS
K955233 · LWF
Corbett Lair, Inc.
Ear, Nose, Throat · 37d
Cleared Dec 21, 1995
TYMPANOSTOMY TUBE
K955447 · ETD
Trebay Medical Corp.
Ear, Nose, Throat · 22d
Cleared Dec 19, 1995
CYBER III OPTION UM, UC312, UC10, UCIC
K955359 · ESD
Qualitone
Ear, Nose, Throat · 27d
Cleared Dec 08, 1995
E-Z BREATHERS
K953042 · LWF
E-Z Kare Good Health Systems, Inc.
Ear, Nose, Throat · 176d
Cleared Dec 08, 1995
TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION
K954579 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 67d
Cleared Dec 08, 1995
RACE CAR TYMPANOMETER
K955289 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 22d
Cleared Dec 06, 1995
FACEPLATE (HEARING AID KIT)
K954236 · ESD
Truetone Hearing Systems, Inc.
Ear, Nose, Throat · 86d
Cleared Dec 06, 1995
TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)
K954912 · EQJ
Trebay Medical Corp.
Ear, Nose, Throat · 44d