FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ear, Nose, Throat ×
3,823 results
3193–3216 of 3,823
Search insights Median review: 65d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 28, 1983
INTRA-ORAL ARTIFICIAL LARYNX
K831127 · ESE
Xomed, Inc.
Ear, Nose, Throat · 113d
Cleared Jul 26, 1983
LASER BRONCHOSCOPE
K831240 · EOQ
Eder Instrument Co, Inc.
Ear, Nose, Throat · 102d
Cleared Jul 26, 1983
HEARING AID G3H & G3T
K832129 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 25d
Cleared Jul 12, 1983
PERSONAL AMPLIFIER MODULE
K830790 · ESD
Electone, Inc.
Ear, Nose, Throat · 120d
Cleared Jul 07, 1983
NEUROTRAC
K831715 · ETN
Hdc Corp.
Ear, Nose, Throat · 41d
Cleared Jul 07, 1983
RIONET HEARING AID -AND/OR RION
K831721 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 37d
Cleared Jul 07, 1983
MA 610-IMPEDANCE AUDIOMETER
K831754 · ETY
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 36d
Cleared Jul 06, 1983
MA600-IMPEDANCE AUDIOMETER
K831755 · ETY
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Jun 30, 1983
CUSTOM IN-THE-EAR HEARING AID
K830960 · ESD
Finetone Hearing Instruments
Ear, Nose, Throat · 97d
Cleared Jun 30, 1983
AUDIOMETER MODEL-500
K831431 · EWO
Audimax
Ear, Nose, Throat · 57d
Cleared Jun 30, 1983
AUDIOSCOPE #23000 W/71123 CHARGING STAND
K831709 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 35d
Cleared Jun 24, 1983
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
K823912 · ETA
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 24, 1983
PARTIAL OSSICULAR REPLACEMENT
K823917 · ETA
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 24, 1983
AUSTIN MODIFIED PARTIAL OSSICULAR RE-
K823918 · ETA
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 24, 1983
TOTAL OSSICULAR REPLACEMENT
K823919 · ETA
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 16, 1983
VENT TUBE FORCEPS
K831589 · EQH
Treace Medical, Inc.
Ear, Nose, Throat · 30d
Cleared Jun 15, 1983
T-TUBE INSERTER
K831590 · EQH
Treace Medical, Inc.
Ear, Nose, Throat · 29d
Cleared Jun 02, 1983
SOILEAU TYTAN BOBBIN VENT TUBE
K830584 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 99d
Cleared May 09, 1983
WIDEX HEARING AID #G2H & G2T
K830465 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 83d
Cleared May 09, 1983
MODEL 343D HEARING AID
K831197 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 27d
Cleared May 09, 1983
MODEL BERNAFON T-86
K831217 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 24d
Cleared Apr 27, 1983
PERSONAL ROMEAR
K823588 · ESD
Romear Mfg., Inc.
Ear, Nose, Throat · 142d
Cleared Apr 27, 1983
COOL-LITE FIBERCOPTIC LARYNGEAL EXAM
K830888 · EQN
National Medical Technology
Ear, Nose, Throat · 37d
Cleared Mar 29, 1983
MECON I
K823788 · ESD
Mecon Labs
Ear, Nose, Throat · 103d