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
1273–1296 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 27, 1996
AHS OMEGA K-AMP
K963875 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 62d
Cleared Nov 27, 1996
STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION...
K964214 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 27, 1996
STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION...
K964244 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d
Cleared Nov 27, 1996
PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC
K964451 · ESD
Rexton, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 27, 1996
UNITRON MODEL SOUND F/XP +4
K964502 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL SOUND F/X +4
K964503 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL ICON AOHPL +4
K964504 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)
K964508 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
K964510 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)
K964511 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT
K964530 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 15d
Cleared Nov 27, 1996
RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
K964557 · ESD
Resound Corp.
Ear, Nose, Throat · 14d
Cleared Nov 26, 1996
MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)
K963745 · ESD
Hearing Innovations, Inc.
Ear, Nose, Throat · 70d
Cleared Nov 26, 1996
IRRIGATION/SUCTION HANDLE AND SHEATH
K963757 · EOB
Richard Wolf Medical Instruments Corp.
Ear, Nose, Throat · 69d
Cleared Nov 26, 1996
STARKEY TM AIR CONDUCTION TINNITUS MASKER
K963838 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 63d
Cleared Nov 26, 1996
AHS OMEGA DEQ
K963873 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
AHS OMEGA AGC
K963874 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
AHS OMEGA PP
K963876 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
AHS DELTA 22
K963879 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
AHS DELTA 22 T
K963881 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 61d
Cleared Nov 26, 1996
STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER
K963995 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 53d
Cleared Nov 26, 1996
AUDIO 'D' SOUND SELECTOR POWER (SSP)
K964180 · ESD
Hearing Solutions, Inc.
Ear, Nose, Throat · 39d
Cleared Nov 08, 1996
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION
K963915 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 39d
Cleared Nov 07, 1996
INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
K961593 · LRB
Segi Hearing Aid Co.
Ear, Nose, Throat · 197d