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
2065–2088 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 27, 1993
WIDEX MODEL D8 (HEARING AID)
K926244 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 47d
Cleared Jan 21, 1993
AE-206 TYMPNOMWRWE(R) AUDIOMETER
K924933 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 113d
Cleared Jan 21, 1993
AUTOMATIC IMPEDANCE METER AE-205
K924934 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 113d
Cleared Jan 15, 1993
THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO
K922383 · EWO
Monitor Instruments, Inc.
Ear, Nose, Throat · 240d
Cleared Jan 15, 1993
BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT
K925173 · LYA
Westmed Intl.
Ear, Nose, Throat · 93d
Cleared Jan 15, 1993
ENDOSHEATH
K925421 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 80d
Cleared Dec 04, 1992
THROAT-A-SCOPE
K923227 · EQH
Truphatek, Ltd.
Ear, Nose, Throat · 156d
Cleared Nov 30, 1992
ULTRACELL NASAL PACKING
K920358 · EMX
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 308d
Cleared Nov 24, 1992
NEUROSIGN MODEL 100
K923056 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 153d
Cleared Nov 24, 1992
P54-0 BEHIND THE EAR HEARING AID
K924887 · ESD
Electone, Inc.
Ear, Nose, Throat · 57d
Cleared Nov 24, 1992
P54 HEARING AID
K924888 · ESD
Electone, Inc.
Ear, Nose, Throat · 57d
Cleared Nov 24, 1992
RLN NERVE LOCATOR/MONITOR
K925008 · ETN
Rln Systems, Inc.
Ear, Nose, Throat · 53d
Cleared Nov 18, 1992
BRANDT ESOPHAGEAL CYTOLOGY BALLOON
K911588 · EOX
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 589d
Cleared Nov 18, 1992
DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
K923847 · EOQ
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 110d
Cleared Nov 16, 1992
HEARING AID (ALL-IN-THE-EAR)
K924350 · ESD
Ear Masters, Inc.
Ear, Nose, Throat · 81d
Cleared Nov 09, 1992
XOMED-TREACE ALPHASCOPE
K923830 · ERA
Xomed-Treace, Inc.
Ear, Nose, Throat · 101d
Cleared Nov 06, 1992
OTO-BRITE HANDLE
K924025 · ERA
Jedmed Instrument Co.
Ear, Nose, Throat · 87d
Cleared Nov 06, 1992
AAHS HEARING AID
K925103 · ESD
American Hearing Systems, Inc.
Ear, Nose, Throat · 29d
Cleared Nov 05, 1992
ST 20 PORTABLE AUDIOMETER
K922746 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 150d
Cleared Nov 04, 1992
PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT
K924911 · ESD
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 04, 1992
PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR
K924913 · ESD
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 04, 1992
PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT
K924914 · ESD
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 03, 1992
DFS GENIUS BTE
K924185 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 75d
Cleared Nov 03, 1992
PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT
K924912 · ESD
Phonak, Inc.
Ear, Nose, Throat · 35d