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
2593–2616 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Oct 31, 1988
UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4
K883961 · ESD
Unimax Hearing Instruments
Ear, Nose, Throat · 41d
Cleared Sep 22, 1988
ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS
K882678 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 86d
Cleared Sep 15, 1988
ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR
K882721 · ESD
Hear-O Inc. C/O L.P. Leale & Assoc.
Ear, Nose, Throat · 76d
Cleared Sep 13, 1988
PUNCH MYRINGOTOMY SYSTEM
K882689 · ETD
Xomed, Inc.
Ear, Nose, Throat · 75d
Cleared Sep 01, 1988
HEARING AID, UNITRON MODEL VISTA 1000
K883513 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 15d
Cleared Aug 30, 1988
MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX
K882691 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 63d
Cleared Aug 26, 1988
ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA
K882471 · ESD
Ear Tech, Inc.
Ear, Nose, Throat · 72d
Cleared Aug 11, 1988
FIRST AMERICAN, RADIONIC, JKR, MODEL AC
K881480 · ESD
Jkr Laboratories, Inc.
Ear, Nose, Throat · 128d
Cleared Aug 10, 1988
LASERMATIC SURGILASER MODEL 5050
K870587 · EWG
Lasermatic OY
Ear, Nose, Throat · 547d
Cleared Aug 10, 1988
EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM
K882744 · EOB
Effner, Inc.
Ear, Nose, Throat · 40d
Cleared Aug 09, 1988
HEARING AID, UNITRON MODEL UI5
K882375 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 62d
Cleared Aug 05, 1988
ITE HEARING AID, EAR-TRONICS MODELS: M1-M23
K881299 · ESD
Ear-Tronics, Inc.
Ear, Nose, Throat · 130d
Cleared Jul 25, 1988
ITE TYPE HEARING AID H.A.F. MODEL ELITE
K881754 · ESD
Brown Hearing Aid Centers
Ear, Nose, Throat · 91d
Cleared Jul 15, 1988
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K881757 · ETN
Downs Surgical , Ltd.
Ear, Nose, Throat · 81d