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
2185–2208 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 24, 1992
EARBEAR OTOSCOPE
K915537 · ERA
Earbear Co.
Ear, Nose, Throat · 45d
Cleared Jan 24, 1992
BTE HEARING AID MULTIFOCUS
K915614 · ESD
Opticon Corp.
Ear, Nose, Throat · 39d
Cleared Jan 24, 1992
PHILIPS 41 SERIES RAINBOW
K920134 · ESD
Philips Int'L B.V.
Ear, Nose, Throat · 11d
Cleared Jan 23, 1992
PHILIPS M60 SERIES
K920142 · ESD
Philips Int'L B.V.
Ear, Nose, Throat · 10d
Cleared Jan 17, 1992
TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER
K915383 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Jan 17, 1992
TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER
K915384 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Jan 17, 1992
TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER
K915397 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Jan 17, 1992
TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER
K915398 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Jan 15, 1992
CUSTOM CANAL HEARING AID
K915346 · ESD
Dicta Laboratories
Ear, Nose, Throat · 50d
Cleared Jan 13, 1992
RIONET HEARING AID HB-71K (K-AMP)
K915875 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 25d
Cleared Jan 10, 1992
SONOTONE BEHIND THE EAR MODEL ST 54-0
K914897 · ESD
Sonotone Intl., Inc.
Ear, Nose, Throat · 71d
Cleared Jan 09, 1992
SONOTONE BEHIND THE EAR MODEL ST 47I
K914898 · ESD
Sonotone Hearing Instruments
Ear, Nose, Throat · 70d
Cleared Jan 09, 1992
SONOTONE BEHIND THE EAR MODEL ST 45G
K914899 · ESD
Sonotone Hearing Instruments
Ear, Nose, Throat · 70d
Cleared Jan 09, 1992
MED-EQUIP CORPORATION
K915076 · ESD
Medequip Co.
Ear, Nose, Throat · 62d
Cleared Jan 09, 1992
RIONET HEARING AID HB-52AS
K915319 · ESD
Rion Co. Ltd. Dba Rion Acoustic Device
Ear, Nose, Throat · 48d
Cleared Jan 09, 1992
SONOTONE BODY AID MODEL ST 1000 BODY WORN
K915517 · ESD
Sonotone Intl., Inc.
Ear, Nose, Throat · 59d
Cleared Jan 09, 1992
SONOTONE BEHIND THE EAR MODEL ST 49
K915518 · ESD
Sonotone Intl., Inc.
Ear, Nose, Throat · 59d
Cleared Jan 09, 1992
SONOTONE BEHIND THE EAR MODEL ST 53A
K915519 · ESD
Sonotone Intl., Inc.
Ear, Nose, Throat · 59d
Cleared Jan 09, 1992
REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION
K915683 · ESD
Rexton, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 09, 1992
REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION
K915684 · ESD
Rexton, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 03, 1992
GRIESHABER TWO FUNCTION MANIPULATOR
K914585 · EQH
Grieshaber & Co.
Ear, Nose, Throat · 79d
Cleared Jan 03, 1992
GRIESHABER THREE FUNCTION MANIPULATOR
K914586 · EQH
Grieshaber & Co.
Ear, Nose, Throat · 79d
Cleared Dec 30, 1991
PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES
K915461 · ESD
Phonak, Inc.
Ear, Nose, Throat · 26d
Cleared Dec 27, 1991
TEF/PLATINUM PISTON
K915120 · ETB
River Medical, Inc.
Ear, Nose, Throat · 44d