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
2929–2952 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 16, 1986
CRAIGWELL AID FITTING SYSTEM AFS
K854125 · EWO
Craigwell Electronics, Ltd.
Ear, Nose, Throat · 99d
Cleared Jan 16, 1986
CRAIGWELL MASTER HEARING AID MHA
K854126 · KHL
Craigwell Electronics, Ltd.
Ear, Nose, Throat · 99d
Cleared Jan 09, 1986
ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY
K853875 · EWG
Endo Lase, Inc.
Ear, Nose, Throat · 114d
Cleared Jan 09, 1986
ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY
K853902 · EWG
Endo Lase, Inc.
Ear, Nose, Throat · 111d
Cleared Jan 06, 1986
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
K852387 · ETD
Xomed, Inc.
Ear, Nose, Throat · 215d
Cleared Jan 06, 1986
GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE
K853641 · ETD
Xomed, Inc.
Ear, Nose, Throat · 125d
Cleared Dec 31, 1985
CERTI-FORM
K854001 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 92d
Cleared Dec 31, 1985
AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B
K854043 · ETY
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 90d
Cleared Dec 27, 1985
MODEL M HEARING AID
K852656 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 186d
Cleared Dec 27, 1985
HI-TECH LAB MODEL CONCHA ALL IN EAR
K853967 · ESD
Hi-Tech Laboratories, Inc.
Ear, Nose, Throat · 92d
Cleared Dec 23, 1985
SHAH SELF-CLEARING MASTOID SUCTION TUBE
K853589 · JZF
Downs Surgical , Ltd.
Ear, Nose, Throat · 118d
Cleared Dec 20, 1985
AUDTEX 85
K853895 · ESD
Cami, Inc.
Ear, Nose, Throat · 91d
Cleared Dec 18, 1985
MODEL 310 IMPEDANCE SYSTEM
K853863 · ETY
Virtual Corp.
Ear, Nose, Throat · 92d
Cleared Dec 18, 1985
MA25 PORTABLE AUDIOMETER
K853919 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 86d
Cleared Dec 18, 1985
INT'L MODEL XG BEHIND-THE-EAR HEARING AID
K853941 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 18, 1985
INT'L MODEL XE BEHIND-THE-EAR HEARING AID
K853942 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 13, 1985
THE GRONINGEN VOICE PROSTHESIS
K853940 · EWL
Hood Laboratories
Ear, Nose, Throat · 80d
Cleared Dec 13, 1985
RESNICK EMITTER, ARTIFICIAL LARYNX
K854158 · ESE
Dynamed Audio, Inc.
Ear, Nose, Throat · 63d
Cleared Dec 02, 1985
WIDEX MODEL M1
K853793 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 82d
Cleared Nov 08, 1985
OE SERIES OF BEHIND-THE-EAR HEARING AIDS
K853381 · ESD
Emtech Laboratories
Ear, Nose, Throat · 88d
Cleared Nov 07, 1985
HEARING AID(ALL IN EAR)
K852244 · ESD
Olympia Instruments, Inc.
Ear, Nose, Throat · 168d
Cleared Nov 07, 1985
UNITRON MODEL UM60-D
K853780 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 59d
Cleared Nov 07, 1985
UNITRON MODEL UM60-PP
K853781 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 59d
Cleared Nov 01, 1985
PERSONAL AMPLIFIER SLIMLINE III
K853605 · ESD
Electone, Inc.
Ear, Nose, Throat · 65d