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
3553–3576 of 3,823
Search insights Median review: 65d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Apr 29, 1980
RADIOEAR MODEL RM-L & RM-C HEARING AID
K800567 · ESD
Radioear Corp.
Ear, Nose, Throat · 47d
Cleared Apr 29, 1980
MINUET MASKER
K800784 · KLW
Beltone Electronics Corp.
Ear, Nose, Throat · 21d
Cleared Apr 24, 1980
JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE
K800623 · KCD
Pilling Co.
Ear, Nose, Throat · 36d
Cleared Apr 24, 1980
RIONET &/OR RION HEARING AID MOD. HB-67S
K800738 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 24, 1980
RIONET &/OR RION HEARING AID MODEL HA-82
K800739 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 21, 1980
FELDMAN MINI-SAW, #300000
K800669 · EWQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 26d
Cleared Apr 16, 1980
GOODE T-TUBE, BIOLITE COATED SILICONE/TU
K800727 · ETD
Xomed, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 16, 1980
PAPARELL TYPE 2, BIOLITE COATED SILI-
K800728 · ETD
Xomed, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 16, 1980
DUNRICH TABLES
K800756 · ETF
Dunrich, Inc.
Ear, Nose, Throat · 12d
Cleared Apr 10, 1980
T-570 TINNITUS MASKER
K800701 · KLW
Audiotrone
Ear, Nose, Throat · 13d
Cleared Apr 08, 1980
SEARS ALL-IN-THE-EAR HEARING AID #8149
K800446 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 40d
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