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
3169–3192 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Sep 29, 1983
BEHIND-THE-EAR SERIES 125
K832751 · ESD
Danavox, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 29, 1983
BLAISE-RATHAEL VOICE PROSTHESIS
K832852 · EWL
Richards Medical Co., Inc.
Ear, Nose, Throat · 44d
Cleared Sep 20, 1983
LARYNGOTELESCOPE CURVED MLC-1
K832449 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 57d
Cleared Sep 20, 1983
BRONCHO FIBERSCOPE FB-19C
K832492 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 55d
Cleared Sep 12, 1983
LARYNGOSCOPE ATTACHMENT PH2000
K831255 · EQN
Eder Instrument Co, Inc.
Ear, Nose, Throat · 147d
Cleared Sep 12, 1983
METAVOX MV-1000 AUDITORY TRAINER
K832190 · EPF
Metavox, Inc.
Ear, Nose, Throat · 66d
Cleared Aug 26, 1983
TACTIL EAR
K831501 · LRA
Ear Three Systems
Ear, Nose, Throat · 107d
Cleared Aug 12, 1983
HEARCO C
K831129 · ESD
Hear Co., Inc.
Ear, Nose, Throat · 128d
Cleared Aug 12, 1983
INSPETOSCOPE
K831614 · ERA
Terayco Intl., Ltd.
Ear, Nose, Throat · 85d
Cleared Aug 12, 1983
HEARING AID UNITRON #UE8-D
K831883 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 60d
Cleared Aug 01, 1983
BRONCHO-FIBERSCOPE
K832010 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 39d
Cleared Aug 01, 1983
PHONIC EAR PE 467R-PE 461T
K832080 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 34d
Cleared Aug 01, 1983
PHONIC EAR PE 845PPC-D
K832081 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 34d
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