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
1369–1392 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared May 07, 1996
AUDIO 'D' INTIMA CIC
K961308 · ESD
Hearing Solutions, Inc.
Ear, Nose, Throat · 33d
Cleared Apr 29, 1996
MILL-ROSE BLIND MICROBIOLOGY BRUSH
K960880 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 56d
Cleared Apr 26, 1996
IRRIGATION SYSTEM
K961192 · ERL
Linvatec Corp.
Ear, Nose, Throat · 31d
Cleared Apr 25, 1996
GASTROTEC
K954401 · ESI
Patrick C. Jacobssen
Ear, Nose, Throat · 218d
Cleared Apr 18, 1996
AM 400
K961084 · ESD
Electone, Inc.
Ear, Nose, Throat · 30d
Cleared Apr 12, 1996
SECOND EAR BONE CONDUCTION HEARING AID
K953872 · LXB
Wordcomp International Communication...
Ear, Nose, Throat · 239d
Cleared Apr 10, 1996
RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES,...
K960680 · ESD
Resound Corp.
Ear, Nose, Throat · 50d
Cleared Apr 10, 1996
HEARING AID - AIR CONDUCTION
K960684 · ESD
Resound Corp.
Ear, Nose, Throat · 50d
Cleared Apr 05, 1996
MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC
K960804 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 37d
Cleared Apr 04, 1996
PERFECT EAR PE/PE-AGC/PE-B/PE-PWR
K960410 · ESD
Perfect Ear
Ear, Nose, Throat · 66d
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