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
2281–2304 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 17, 1991
QUALITONE MODEL 48 C-WR-BEHIND THE EAR
K912154 · ESD
Qualitone
Ear, Nose, Throat · 33d
Cleared Jun 07, 1991
PHILIPS M30 IN-THE-EAR HEARING AID
K912339 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 14d
Cleared May 30, 1991
RIVER MEDICAL MICRODRILL SYSTEM
K905437 · EQH
River Medical, Inc.
Ear, Nose, Throat · 177d
Cleared May 30, 1991
FACEPLATE ITE HEARING AID MODEL TCA
K910900 · LRB
Telex Communications, Inc.
Ear, Nose, Throat · 86d
Cleared May 30, 1991
FACEPLATE ITE HEARING AID MODEL 28A
K910901 · LRB
Telex Communications, Inc.
Ear, Nose, Throat · 86d
Cleared May 28, 1991
WIDEX MODEL QX IN-THE-EAR HEARING AID
K912169 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 12d
Cleared May 23, 1991
LM-150HT LIGHT SOURCE
K911212 · ESI
Leisegang Medical, Inc.
Ear, Nose, Throat · 65d
Cleared May 17, 1991
CHAMPION, BEHIND-THE-EAR HEARING AID
K911705 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
MODEL 800, BEHIND-THE-EAR HEARING AID
K911706 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
REGAL, BEHIND-THE-EAR HEARING AID
K911707 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
MODEL E-50, IN-THE-EAR HEARING AID
K911708 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
STOCK CANAL, IN-THE-EAR HEARING AID
K911709 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 15, 1991
#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES
K910781 · ETF
Midmark Corp.
Ear, Nose, Throat · 79d
Cleared May 09, 1991
NHS 2009SP HEARING AID
K911174 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 52d
Cleared May 09, 1991
NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS
K911182 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 52d
Cleared May 07, 1991
STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS
K911579 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 35d
Cleared Apr 30, 1991
DR. DEDO'S FAMILY EAR EXAMINATION KIT
K904659 · ERA
Panex Corp.
Ear, Nose, Throat · 197d
Cleared Apr 30, 1991
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
K905704 · ETY
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 130d
Cleared Apr 29, 1991
BRONCHOSCOPE BF-N20
K910423 · EOQ
Olympus Corp.
Ear, Nose, Throat · 89d
Cleared Apr 22, 1991
X-T AIR DRILL
K905800 · ERL
Xomed-Treace, Inc.
Ear, Nose, Throat · 115d
Cleared Apr 19, 1991
AXOSTIM NERVE STIMULATOR, MODIFICATION
K905035 · ETN
Singer Medical Products, Inc.
Ear, Nose, Throat · 176d
Cleared Apr 19, 1991
CUSTOM PERSONAL EAR - CPE
K911497 · ESD
Qualitone
Ear, Nose, Throat · 18d
Cleared Apr 19, 1991
ADJUSTRETTE - DAO, MODIFICATION
K911498 · ESD
Qualitone
Ear, Nose, Throat · 21d
Cleared Apr 19, 1991
ELEGANCE - DEO, MODIFICATION
K911499 · ESD
Qualitone
Ear, Nose, Throat · 21d