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
1993–2016 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 01, 1993
MT 80 SP
K931040 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 01, 1993
STAR 42 PP-SP, STAR 42 PP-SL (T100)
K931041 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 01, 1993
SERIES STAR 66 BEKHIND THE EAR HEARING AID
K931160 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared Jun 01, 1993
SERIES STAR 22 - BEHIND THE EAR HEARING AID
K931161 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared May 19, 1993
ITE MODEL ADOBE 100 FULL CUSTOM
K931590 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 49d
Cleared May 19, 1993
ITC MODEL ADOBE 100 CANAL
K931591 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 49d
Cleared May 18, 1993
VENTILATION TUBES W/ HYDROGEL COATING
K923353 · ETD
Microbio-Medics, Inc.
Ear, Nose, Throat · 314d
Cleared May 17, 1993
BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.
K930105 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 126d
Cleared May 17, 1993
NASAL/PARANASAL ENDOSCOPE
K930931 · EOB
Storz Instrument Co.
Ear, Nose, Throat · 83d
Cleared May 05, 1993
AUTOMATIC CALORIC IRRIGATION SYSTEM
K925237 · KHH
Ics Medical Corp.
Ear, Nose, Throat · 201d
Cleared May 05, 1993
BEL-AIR VENTILATION TUBE
K926462 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 132d
Cleared May 05, 1993
IN-THE-EAR HEARING AID
K931023 · ESD
Hearing Improvement
Ear, Nose, Throat · 65d
Cleared May 05, 1993
RIONET HEARING AID HB-53W
K931320 · ESD
Rion Co. Ltd. Dba Rion Acoustic Device
Ear, Nose, Throat · 50d
Cleared Apr 26, 1993
SURGICAL TRAY (STERILE)
K925022 · LRD
Customed, Inc.
Ear, Nose, Throat · 214d
Cleared Apr 23, 1993
THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S
K930164 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 100d
Cleared Apr 23, 1993
AE-207D TYMPANOMETER
K930165 · ETY
Amrex Electronics, Inc.
Ear, Nose, Throat · 100d
Cleared Apr 14, 1993
BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP
K931134 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 40d
Cleared Apr 14, 1993
BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP
K931157 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 37d
Cleared Apr 14, 1993
MEMOREX MODEL 361-AGCO HEARING AID
K931158 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 37d
Cleared Apr 12, 1993
SIEMENS MODEL 584-P-GC
K930998 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 45d
Cleared Apr 12, 1993
SIEMENS MODEL 584-P-AI
K930999 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 45d
Cleared Apr 12, 1993
SIEMENS MODEL 584-P-AI-D
K931000 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 45d
Cleared Apr 09, 1993
BENSON CCA100
K924652 · EWG
Benson Medical Instruments Co.
Ear, Nose, Throat · 206d
Cleared Apr 07, 1993
LECTRO-LARYNX
K923648 · ESE
Bruce Medical Supply
Ear, Nose, Throat · 260d