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
1369–1392 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 11, 1996
TYMPANOSTOMY VENTILATION TUBE
K961945 · ETD
Advanced Microbotics Corp.
Ear, Nose, Throat · 22d
Cleared May 30, 1996
BREATHE RIGHT NASAL STRIP
K955711 · LWF
Cns, Inc.
Ear, Nose, Throat · 164d
Cleared May 29, 1996
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE)...
K961447 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 43d
Cleared May 29, 1996
PHONAK SONA P2
K961653 · ESD
Phonak, Inc.
Ear, Nose, Throat · 29d
Cleared May 29, 1996
ARGOSY PROGRAMMABLE
K961729 · ESD
Argosy Electronics
Ear, Nose, Throat · 26d
Cleared May 17, 1996
PHONAK PICONET2 P2 AZ
K961622 · ESD
Phonak, Inc.
Ear, Nose, Throat · 21d
Cleared May 14, 1996
POLY/PLATINUM WIRE PISTON
K945105 · ETB
Micromed Development Corp.
Ear, Nose, Throat · 574d
Cleared May 14, 1996
KARL STORZ INTUBATION FIBERSCOPE
K961178 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 49d
Cleared May 14, 1996
CLARITY
K961670 · ESD
Seig Technologies, Inc.
Ear, Nose, Throat · 14d
Cleared May 08, 1996
FIVE STAR BRONCHOSCOPE
K960876 · EOB
Five Star Medical, Inc.
Ear, Nose, Throat · 65d
Cleared May 07, 1996
COMFORTONE PHS
K960741 · ESD
Comfortone America'S Value Hearing...
Ear, Nose, Throat · 74d
Cleared May 07, 1996
DIGIFOCUS COMPACT
K961059 · ESD
Oticon, Inc.
Ear, Nose, Throat · 50d
Cleared May 07, 1996
TECHNA TONE
K961082 · ESD
Techna Tone
Ear, Nose, Throat · 50d
Cleared May 07, 1996
TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40
K961143 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 47d
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