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
2305–2328 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 19, 1991
ULTRA & ULTRA LITE II, MODIFICATION
K911504 · ESD
Qualitone
Ear, Nose, Throat · 16d
Cleared Apr 17, 1991
THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER
K900197 · EWO
Sound Linked Data, Inc.
Ear, Nose, Throat · 456d
Cleared Apr 17, 1991
MOBILE TREATMENT CART
K910243 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 85d
Cleared Apr 17, 1991
PHONAK 9800 SC-AF ITE HEARING INSTRUMENT
K911210 · ESD
Phonak, Inc.
Ear, Nose, Throat · 29d
Cleared Apr 17, 1991
PHONAK 9100 SC-AF ITE HEARING INSTRUMENT
K911211 · ESD
Phonak, Inc.
Ear, Nose, Throat · 29d
Cleared Apr 15, 1991
AHL, ITE MODEL AMERICAN
K910325 · ESD
Bob Bare Hearing Aid Repair
Ear, Nose, Throat · 81d
Cleared Apr 15, 1991
PHONAK 9300 SC-AF ITE HEARING INSTRUMENT
K911209 · ESD
Phonak, Inc.
Ear, Nose, Throat · 27d
Cleared Apr 09, 1991
MODEL FT40 TRANSONIC(TM) HEARING AID
K905516 · ESD
Sonovation, Inc. Dba Avr Sonovation
Ear, Nose, Throat · 123d
Cleared Apr 03, 1991
RESORBABLE BONE PLUG
K905740 · ESD
Zimmer, Inc.
Ear, Nose, Throat · 100d
Cleared Apr 03, 1991
ELECTONE ITE MODEL PREMIER
K910097 · ESD
Electone, Inc.
Ear, Nose, Throat · 84d
Cleared Mar 29, 1991
GSI 37 AUTO TYMP
K911095 · ETY
Lucas Grason-Stadler, Inc.
Ear, Nose, Throat · 16d
Cleared Mar 21, 1991
EXPANDACEL NASAL TAMPONS
K904624 · EMX
Ron Shippert, MD
Ear, Nose, Throat · 161d
Cleared Mar 21, 1991
DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID
K910809 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 23d
Cleared Mar 21, 1991
DAHLBERG MODEL LT BTE HEARING AID
K910979 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 14d
Cleared Mar 21, 1991
DAHLBERG MODEL LU BTE HEARING AID
K911063 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 10d
Cleared Mar 21, 1991
DAHLBERG MODEL LG BTE HEARING AID
K911064 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 10d
Cleared Mar 21, 1991
DAHLBERG MODEL LZ BTE HEARING AID
K911096 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 9d
Cleared Mar 18, 1991
CUSTOM ITE HEARING AID
K905784 · ESD
Hearing Aid Co.
Ear, Nose, Throat · 90d
Cleared Mar 18, 1991
ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID
K910311 · ESD
Ototech, Ltd.
Ear, Nose, Throat · 53d
Cleared Mar 18, 1991
C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID
K910312 · ESD
Ototech, Ltd.
Ear, Nose, Throat · 53d
Cleared Mar 18, 1991
ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID
K910313 · ESD
Ototech, Ltd.
Ear, Nose, Throat · 53d
Cleared Mar 18, 1991
C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID
K910314 · ESD
Ototech, Ltd.
Ear, Nose, Throat · 53d
Cleared Mar 15, 1991
MATRICS
K904756 · ESD
Kerr Corporation (Danbury)
Ear, Nose, Throat · 147d
Cleared Mar 15, 1991
NERVE LOCATOR/STIMULATOR
K905045 · ETN
Aaron Medical Industries
Ear, Nose, Throat · 127d