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
2593–2616 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Mar 09, 1989
BTE HEARING AID OTICON MODEL: E42P
K890704 · ESD
Oticon Corp.
Ear, Nose, Throat · 27d
Cleared Mar 01, 1989
WIDEX BTE HEARING AID MODEL Q8
K885128 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 79d
Cleared Feb 27, 1989
BALANCE SYSTEM
K884926 · LXV
Chattanooga Group, Inc.
Ear, Nose, Throat · 91d
Cleared Feb 22, 1989
AUDIOMETER DIGITAL HEARING SYSTEM
K884044 · EWO
Resound Corp.
Ear, Nose, Throat · 149d
Cleared Feb 22, 1989
RESOUND HES, DIGITALLY PROGR., ITE HEARING AID
K884871 · ESD
Resound Corp.
Ear, Nose, Throat · 93d
Cleared Feb 15, 1989
ENDOSTROBOSCOPE IV
K884933 · EQL
Jedmed Instrument Co.
Ear, Nose, Throat · 79d
Cleared Feb 13, 1989
AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500
K884046 · ETW
Etymonic Design, Inc.
Ear, Nose, Throat · 140d
Cleared Feb 13, 1989
MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
K884371 · ETW
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 118d
Cleared Feb 13, 1989
MADSEN IGO1500 INSERTION GAIN OPTIMIZER
K884372 · ETW
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 118d
Cleared Jan 27, 1989
MICROSURGICAL WIRE LOOP
K890221 · JYQ
Kinetic Medical Products
Ear, Nose, Throat · 9d
Cleared Jan 18, 1989
CRUCIOMETER
K884483 · JZE
Orthopedic Systems, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 18, 1989
BTE HEARING AID SIEMENS MODEL 284PP-ASP
K884583 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 77d
Cleared Jan 13, 1989
ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID
K882633 · ESD
Ensoniq Corp.
Ear, Nose, Throat · 200d
Cleared Jan 13, 1989
BUCKET PROSTHESIS PORP
K883727 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 135d
Cleared Jan 03, 1989
AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER
K883728 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 125d
Cleared Jan 03, 1989
HEARING AID, UNITRON BTE MODEL UM60-AGC0
K884288 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 83d
Cleared Dec 19, 1988
HEARING AID WIDEX BTE
K884113 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 81d
Cleared Dec 07, 1988
OTOMETER PORTABLE SCREENING AUDIOMETER
K883169 · EWO
Otometer, Inc.
Ear, Nose, Throat · 133d
Cleared Nov 30, 1988
MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
K884056 · LXB
Xomed, Inc.
Ear, Nose, Throat · 65d
Cleared Nov 17, 1988
DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
K883478 · EWO
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 93d
Cleared Nov 17, 1988
ETA
K883853 · LRA
Sevrain-Tech, Inc.
Ear, Nose, Throat · 65d
Cleared Nov 14, 1988
DONALDSON VENTILATION TUBES PT. # AG/S9
K883667 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 80d
Cleared Nov 14, 1988
H.A.C. MODEL-A (ALL IN THE EAR)
K883772 · ESD
Hearing Aid Crafters
Ear, Nose, Throat · 69d
Cleared Nov 14, 1988
H.A.C. MODEL-B (ALL IN THE CANAL)
K883773 · ESD
Hearing Aid Crafters
Ear, Nose, Throat · 69d