FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,798 results
2329–2352 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Feb 28, 1991
PHILIPS MODEL S46-O BTE HEARING AID
K910744 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 7d
Cleared Feb 28, 1991
3M MODEL 8241 ITE HEARING AID
K910759 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8242 ITE HEARING AID
K910760 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8243 ITE HEARING AID
K910761 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8244 ITE HEARING AID
K910762 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8245 ITE HEARING AID
K910763 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 20, 1991
MIDDLE EAR ANALYZER, MODEL AE-803
K905213 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 92d
Cleared Feb 19, 1991
IMMITTANCE METER, MODEL AE-105D/S
K905212 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 91d
Cleared Feb 05, 1991
PHILIPS MODEL S47 BTE HEARING AID
K910206 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ACOUSTIQ LISTENING DEVICE
K904755 · LZI
Krueger Laboratories
Ear, Nose, Throat · 102d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM900 PP
K910096 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 240 HF
K910099 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 130 D
K910100 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 130 PP
K910101 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 240 PPL
K910102 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 130 HF
K910103 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
AM130 AGC-O (BEHIND THE EAR) HEARING AID
K910148 · ESD
Electone, Inc.
Ear, Nose, Throat · 15d
Cleared Jan 28, 1991
BOBBIN STYLE VENTURI
K904592 · ETD
River Medical, Inc.
Ear, Nose, Throat · 110d
Cleared Jan 28, 1991
COLLAR BUTTON STYLE VENTURI
K904594 · ETD
River Medical, Inc.
Ear, Nose, Throat · 110d
Cleared Jan 28, 1991
GROMMET STYLE VENTURI
K904597 · ETD
River Medical, Inc.
Ear, Nose, Throat · 110d
Cleared Jan 28, 1991
133 SERIES BTE
K905679 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 28, 1991
143 SERIES BTE
K905692 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 28, 1991
ELECTONE BTE MODEL AM 240 PPI
K910098 · ESD
Electone, Inc.
Ear, Nose, Throat · 19d
Cleared Jan 22, 1991
VIDEO OTOSCOPE
K904802 · ERA
Jedmed Instrument Co.
Ear, Nose, Throat · 90d