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
2425–2448 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared May 29, 1990
AUDIOTONE ITE HEARING AID MODEL ZA (MICRO)
K901783 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 23, 1990
WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE
K897033 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 156d
Cleared May 23, 1990
MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID
K897035 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 156d
Cleared May 23, 1990
PHONAK ITE 8000, 7000, 6000 ITE HEARING AID
K900675 · ESD
Phonak, Inc.
Ear, Nose, Throat · 100d
Cleared May 23, 1990
BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC
K900829 · ESD
Phonak, Inc.
Ear, Nose, Throat · 91d
Cleared May 23, 1990
BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4
K900830 · ESD
Phonak, Inc.
Ear, Nose, Throat · 91d
Cleared May 23, 1990
BTE PICO SCD, PICO SC
K900831 · ESD
Phonak, Inc.
Ear, Nose, Throat · 91d
Cleared May 23, 1990
MODEL 366 HEARING AID
K900846 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 90d
Cleared May 23, 1990
WIDEX HEARING AID MODEL THE DISCOVERY
K901642 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 44d
Cleared May 21, 1990
SIEMENS MODEL 284 PP-L
K893573 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 284 PP-AGC
K893574 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d