FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ear, Nose, Throat ×
3,823 results
2425–2448 of 3,823
Search insights Median review: 65d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 27, 1990
REXTON RX12 POWER PLUS W/DUAL RECEIVER
K901341 · ESD
Rexton, Inc.
Ear, Nose, Throat · 127d
Cleared Jul 27, 1990
HERITAGE III (HTC) ITC TYPE HEARING AID
K903023 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 20, 1990
INTRA III AND INTRA IV HEARING AIDS
K901860 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 87d
Cleared Jul 13, 1990
GSI 17 SCREENING AUDIOMETER
K902540 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 37d
Cleared Jul 09, 1990
CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P
K902559 · ESD
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Jul 09, 1990
ADAM MARK II CUSTOM IN-THE-EAR HEARING AID
K902570 · ESD
Adams Hearing Aid Center
Ear, Nose, Throat · 31d
Cleared Jun 28, 1990
ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM
K901503 · ESE
Stanton Magnetics, Inc.
Ear, Nose, Throat · 90d
Cleared Jun 28, 1990
ELECTROGLOTTOGRAPH
K901609 · KLX
Glottal Ent., Inc.
Ear, Nose, Throat · 83d
Cleared Jun 26, 1990
AUDIOTESTER SCREENING AUDIOMETER
K894484 · EWO
Prometex, Inc.
Ear, Nose, Throat · 343d
Cleared Jun 14, 1990
EXPANDACEL NASAL TAMPONS
K900171 · EMX
Surgitrend, Ltd.
Ear, Nose, Throat · 153d
Cleared Jun 14, 1990
JAHN VENTILATION TUBE
K900267 · ETD
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 147d
Cleared Jun 14, 1990
BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT
K900518 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 132d
Cleared Jun 14, 1990
INVOTEC BI-VALVE SPLINT
K901306 · LYA
Invotec International, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 14, 1990
PASSAGE AIRWAY SPLINT
K901307 · LYA
Invotec International, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 14, 1990
ULTRASTAT NASAL CATHETER
K901310 · EMX
Invotec International, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 14, 1990
INVOTEC SEPTAL BUTTON
K901366 · LFB
Invotec International, Inc.
Ear, Nose, Throat · 83d
Cleared Jun 14, 1990
BARTON-MAYO TRACHEOSTOMA BUTTON
K901377 · KAC
Medical Innovations International, Inc.
Ear, Nose, Throat · 84d
Cleared Jun 14, 1990
CUSTOM ITE HEARING AID MODELS C AND M
K902351 · ESD
Oticon Corp.
Ear, Nose, Throat · 16d
Cleared Jun 14, 1990
CUSTOM ITE HEARING AID MODEL: H
K902352 · ESD
Oticon Corp.
Ear, Nose, Throat · 16d
Cleared Jun 14, 1990
CUSTOM ITE HEARING AID MODELS F AND L
K902353 · ESD
Oticon Corp.
Ear, Nose, Throat · 16d
Cleared May 31, 1990
INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)
K900096 · EWO
Artifical Hearing Systems Corp.
Ear, Nose, Throat · 143d
Cleared May 29, 1990
AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST.
K901745 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 29, 1990
AUDIOTONE ITE HEARING AID MODEL ZD (XT)
K901746 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 29, 1990
AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE)
K901747 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d