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
1849–1872 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 01, 1994
BELTONE OPERA/OPERA MHP/OPERA MAX
K940102 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
BELTONE ODE AND BELTONE ODE VX
K940103 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP)
K940177 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 80d
Cleared Mar 25, 1994
LORI-CIC HEARING AID
K940639 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 39d
Cleared Mar 24, 1994
JAW SPREADER
K936050 · KBW
Gam Industries, Inc.
Ear, Nose, Throat · 94d
Cleared Mar 24, 1994
ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3
K936257 · EOB
Mitsubishi Cable America, Inc.
Ear, Nose, Throat · 84d
Cleared Mar 24, 1994
OTOSONIC MINI PAS
K940104 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 73d
Cleared Mar 23, 1994
FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE
K933770 · LRC
Mahe-Medizintechnik
Ear, Nose, Throat · 237d
Cleared Mar 22, 1994
AIR CONDUCTION HEARING AID, UNITRON IKON K & KD
K935867 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 106d
Cleared Mar 22, 1994
PHONIC EAR
K940313 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 57d
Cleared Mar 21, 1994
AIR CONDUCTION HEARING AID: IKON PP
K936106 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 89d
Cleared Mar 21, 1994
RIONET HEARING AID HB-53CI
K936122 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 88d
Cleared Mar 21, 1994
MIRACLE-EAR CONFIDANTE
K940458 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 48d
Cleared Mar 17, 1994
WIDEX R.C. 2 (REMOTE CONTROL)
K935424 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 127d
Cleared Mar 16, 1994
NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX
K934483 · ESE
Mountain Precision Mfg. Ltd. Co.
Ear, Nose, Throat · 183d
Cleared Mar 07, 1994
RESOLUTION(TM) HIP STEM
K933570 · LJW
Wrightmedicaltechnologyinc
Ear, Nose, Throat · 227d
Cleared Mar 07, 1994
MIRACLE-EAR ENTRE
K934940 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 140d
Cleared Mar 04, 1994
MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT
K935658 · LYA
Merocel Corp.
Ear, Nose, Throat · 100d
Cleared Mar 04, 1994
PRIZM HEARING SYSTEM, MODEL POWER BTE
K936007 · ESD
Audioscience, Inc.
Ear, Nose, Throat · 78d
Cleared Feb 22, 1994
PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS
K932853 · JEL
Applied Osteo Systems, Inc.
Ear, Nose, Throat · 257d
Cleared Feb 22, 1994
MEDNEXT BUR
K935584 · EQJ
Mednext, Inc.
Ear, Nose, Throat · 96d
Cleared Feb 18, 1994
OTOACOUSTIC EMISSIONS UNIT CELESTA 503
K931325 · EWO
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 339d
Cleared Feb 16, 1994
ASPIRATING ENDO OCULAR PROBE
K930123 · EQH
Surgical Technologies, Inc.
Ear, Nose, Throat · 400d
Cleared Feb 09, 1994
ARTISAN PROGRAMMER & HEARING AID
K935048 · LRB
Telex Communications, Inc.
Ear, Nose, Throat · 111d