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
1393–1416 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 03, 1996
THE VIRTUAL M-332
K960500 · EWD
Virtual Corp.
Ear, Nose, Throat · 61d
Cleared Apr 03, 1996
TYMPANOSTOMY VENTILATION TUBE
K960742 · ETD
Advanced Microbotics Corp.
Ear, Nose, Throat · 40d
Cleared Apr 03, 1996
ACE SYSTEM
K960853 · EQJ
Xomed, Inc.
Ear, Nose, Throat · 33d
Cleared Apr 03, 1996
AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL,...
K960935 · ESD
Hearing Solutions, Inc.
Ear, Nose, Throat · 26d
Cleared Mar 22, 1996
LONG LIFE RX-12
K960295 · ESD
Rexton, Inc.
Ear, Nose, Throat · 60d
Cleared Mar 12, 1996
RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241
K960052 · ESD
Resound Corp.
Ear, Nose, Throat · 68d
Cleared Mar 11, 1996
KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS
K960791 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 13d
Cleared Mar 07, 1996
AUDIOFLEX 120
K960031 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 65d
Cleared Mar 07, 1996
UNITRON MODEL SOUND F/XP
K960155 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 56d
Cleared Mar 07, 1996
RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM
K960229 · ETW
Resound Corp.
Ear, Nose, Throat · 50d
Cleared Mar 07, 1996
OTICON /PRIMOFOCUS (PF)
K960284 · ESD
Oticon, Inc.
Ear, Nose, Throat · 48d
Cleared Mar 01, 1996
BELTONE COMPOSER 2000 BTE HP
K955930 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 71d
Cleared Mar 01, 1996
EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS
K960494 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 31d
Cleared Feb 27, 1996
BREATHE RIGHT NASAL STRIP
K954914 · LWF
Cns, Inc.
Ear, Nose, Throat · 124d
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