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
3553–3576 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 08, 1980
SEARS ALL-IN-THE-EAR HEARING AID #8149HF
K800447 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 40d
Cleared Mar 25, 1980
BLOM-SINGER DUCKBILL VOICE PROSTHESIS
K800563 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 12d
Cleared Mar 20, 1980
DAHLBERG #AZ BEHIND THE EAR HEARING AID
K800571 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 6d
Cleared Mar 19, 1980
BEHIND EAR HEARING AID MODEL E24C1
K800244 · ESD
Oticon Corp.
Ear, Nose, Throat · 43d
Cleared Mar 18, 1980
SMR H-CHAIR
K800526 · ETF
Surgical Mechanical Research, Inc.
Ear, Nose, Throat · 11d
Cleared Mar 12, 1980
MODEL 795U BEHIND THE EAR HEARING AID
K800345 · ESD
Danavox, Inc.
Ear, Nose, Throat · 22d
Cleared Mar 12, 1980
EDINBURGH MASKER
K800445 · KTH
Foundation For Fluency, Inc.
Ear, Nose, Throat · 13d
Cleared Mar 10, 1980
EARSCOPE
K800365 · ERA
Nash & Assoc.
Ear, Nose, Throat · 19d
Cleared Mar 10, 1980
VARIOTHERM
K800442 · ETP
Jedmed Instrument Co.
Ear, Nose, Throat · 11d
Cleared Mar 10, 1980
HYGROTHERM
K800443 · ETP
Jedmed Instrument Co.
Ear, Nose, Throat · 11d
Cleared Mar 05, 1980
RADIOEAR MODEL 2080 (HEARING AID)
K800332 · ESD
Radioear Corp.
Ear, Nose, Throat · 20d
Cleared Feb 28, 1980
DAHLBERG # AF BEHING THE EAR HEARING/AID
K800181 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 30d
Cleared Feb 26, 1980
AUDIONICS PB MAX HEARING AID
K800269 · ESD
Audionics Corp.
Ear, Nose, Throat · 20d
Cleared Feb 26, 1980
OTICON MODEL E17VF EARETTE HEARING AID
K800283 · ESD
Oticon Corp.
Ear, Nose, Throat · 18d
Cleared Feb 26, 1980
OTICON MODEL E19VF EARETTE HEARING AID
K800316 · ESD
Oticon Corp.
Ear, Nose, Throat · 14d
Cleared Feb 26, 1980
PHONIC EAR, MODEL 841L
K800340 · ESD
Hc Electronics
Ear, Nose, Throat · 11d
Cleared Feb 21, 1980
NASOSTAT
K800175 · EMX
Edward Weck, Inc.
Ear, Nose, Throat · 24d
Cleared Feb 11, 1980
TELESONIC (HEARING AID)
K800105 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 26d
Cleared Feb 11, 1980
SEARS BEHIND-THE-EAR HEARING AID
K800113 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 26d
Cleared Jan 29, 1980
RIONET HEARING AID HE-71
K800011 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jan 29, 1980
RIONET HEARING AID HA-61
K800012 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jan 23, 1980
WIDEX HEARING AID MODEL S10
K792389 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 58d
Cleared Jan 23, 1980
COE-SIL
K792428 · LDG
Coe Laboratories, Inc.
Ear, Nose, Throat · 57d
Cleared Jan 23, 1980
WIDEX HEARING AID MODEL 820
K792567 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 58d