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
1921–1944 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Oct 08, 1993
POWER 3-CHANNEL-CLOCK
K934448 · ESD
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 08, 1993
3-CHANNEL K-AMP
K934449 · ESD
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 08, 1993
MANHATTAN 3-CHANNEL
K934450 · ESD
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 08, 1993
3-CHANNEL CLOCK
K934453 · ESD
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 08, 1993
MANHATTAN II
K934454 · ESD
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 07, 1993
BREATHE RIGHT
K921220 · LWF
Cns, Inc.
Ear, Nose, Throat · 573d
Cleared Oct 07, 1993
EVIS 200 SYSTEM
K931154 · EOQ
Olympus Corp.
Ear, Nose, Throat · 213d
Cleared Oct 07, 1993
STARKEY TYMPANETTE HEARING AID
K933407 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 87d
Cleared Oct 07, 1993
BOSCH EUROSTAR
K933988 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 51d
Cleared Oct 07, 1993
RESOLUTION ITC HEARING AID
K933989 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 51d
Cleared Sep 29, 1993
CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT
K930553 · EWO
Etymotic Research
Ear, Nose, Throat · 238d
Cleared Sep 18, 1993
AS-90
K923006 · ESD
Qualitone
Ear, Nose, Throat · 453d
Cleared Sep 07, 1993
FIBEROPTIC LIGHTSOURCES AND CARRIERS
K933145 · EQH
Electro Fiberoptics Corp.
Ear, Nose, Throat · 71d
Cleared Sep 07, 1993
PHILIPS 45 SERIES
K933850 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 32d
Cleared Aug 30, 1993
GM SWIVEL VIDEO (TM) IRRIGATOR
K931398 · KAR
Gm Engineering, Inc.
Ear, Nose, Throat · 164d
Cleared Aug 25, 1993
DENRICK SPEECH AID (DR-1)
K931371 · ESE
Denrick Corp.
Ear, Nose, Throat · 161d
Cleared Aug 25, 1993
LANGGASSE 90
K932470 · ETF
Happersberger Otopront GmbH
Ear, Nose, Throat · 97d
Cleared Aug 23, 1993
MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID
K933291 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 48d
Cleared Aug 23, 1993
MULTIFOCUS COMPACT BTE HEARING AID
K933307 · ESD
Oticon, Inc.
Ear, Nose, Throat · 47d
Cleared Aug 23, 1993
MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID
K933579 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 31d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 12 (L12)
K933640 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 6 (L6)
K933643 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 8 (L8)
K933644 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 19, 1993
BELTONE PRIMA 2000
K932703 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 77d