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
2041–2064 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Mar 18, 1993
CE-9 IN-THE-EAR HEARING AID
K930805 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared Mar 18, 1993
INTRA V AND SECRET EAR III
K930853 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Mar 16, 1993
FLEXIBLE TROCAR TUBES
K930215 · EWY
Olympus Corp.
Ear, Nose, Throat · 61d
Cleared Mar 08, 1993
INCUDOSTAPEDIAL JOINT
K925443 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 131d
Cleared Mar 04, 1993
AUDIOSCAN
K926336 · EWO
Electrocaine Medical System
Ear, Nose, Throat · 78d
Cleared Mar 03, 1993
VOICEMODE, ITE, AIR-CONDUCTION HEARING AID
K930541 · ESD
Personal Sound Technologies, Inc.
Ear, Nose, Throat · 29d
Cleared Mar 01, 1993
BELTONE OPTIMA 2000 CLEARVOICE SERIES, IN-THE-EAR
K930310 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 38d
Cleared Mar 01, 1993
BELTONE OPERA LOR, ITC
K930318 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 38d
Cleared Feb 26, 1993
AT-2
K923007 · EWO
Qualitone
Ear, Nose, Throat · 249d
Cleared Feb 26, 1993
DSP SCREENING AUDIOMETER
K924543 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 171d
Cleared Feb 19, 1993
AUTOMATIC TYMPANOMETER
K923073 · ETY
Life-Tech Intl., Inc.
Ear, Nose, Throat · 239d
Cleared Feb 19, 1993
JACK'S VENT TUBES
K923887 · ETD
O.R. Specialties, Inc.
Ear, Nose, Throat · 199d
Cleared Feb 12, 1993
AMERICAN ARTIFICIAL LARYNX
K914816 · ESE
Ultravoice, Ltd.
Ear, Nose, Throat · 476d
Cleared Feb 12, 1993
TITANIUM VENTILATION TUBES
K921923 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 310d
Cleared Feb 12, 1993
NASAL-SINUS PACKING
K924542 · EMX
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 157d
Cleared Feb 12, 1993
AUDIOTONE MODEL A-98
K926091 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 72d
Cleared Feb 12, 1993
MIRACLE-EAR MODEL HL
K926092 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 72d
Cleared Feb 08, 1993
VISTA 4000 SIGMA
K925600 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 95d
Cleared Feb 02, 1993
GSI 38 AUTO TYMP
K925585 · ETY
Lucas Grason-Stadler, Inc.
Ear, Nose, Throat · 90d
Cleared Feb 02, 1993
WIDEX MODEL D16
K926085 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 62d
Cleared Feb 02, 1993
SOUNDCHOICE WITH VARIABLE SLOPE
K926476 · ESD
Bausch & Lomb, Inc.
Ear, Nose, Throat · 35d
Cleared Feb 01, 1993
ULTRACELL EAR WICK
K920357 · KCN
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 371d
Cleared Feb 01, 1993
PHONAK PICONET 231-X
K930145 · ESD
Phonak, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 28, 1993
DEANS DISPOSABLE T-TUBE INSERTER
K924901 · JYM
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 141d