FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,798 results
1825–1848 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 26, 1994
AURAL-CAM, VIDEO EAR, VID RX
K941659 · ERA
Gracefully Yours, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 25, 1994
OTOVIEW ENDOSCOPY SYSTEM
K934432 · EWA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 224d
Cleared Apr 22, 1994
PRODIGIT 2000
K940999 · EWO
Calmed Technology, Inc.
Ear, Nose, Throat · 49d
Cleared Apr 15, 1994
BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES
K932120 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 347d
Cleared Apr 14, 1994
TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES
K940903 · KBM
Medical Insights, Inc.
Ear, Nose, Throat · 49d
Cleared Apr 04, 1994
BEHIND THE EAR HEARING AID
K936190 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 98d
Cleared Apr 01, 1994
MID LABS TWIN ILLUMINATOR
K932131 · EQH
Medical Instrument Development...
Ear, Nose, Throat · 333d
Cleared Apr 01, 1994
OTOSONIC (OSI) LPS D
K940099 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
PROFILE IC
K940100 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
OTOSONIC ACS II D WITH SRR
K940101 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
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