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
1297–1320 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Nov 07, 1996
KARL STORZ CONTACT MICRO-LARYNGOSCOPES
K963426 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 69d
Cleared Nov 07, 1996
IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING...
K964113 · EMX
M-Pact Worldwide Management Corp.
Ear, Nose, Throat · 23d
Cleared Nov 04, 1996
RESOUND CC4 PERSONAL HEARING SYSTEM
K964115 · ESD
Resound Corp.
Ear, Nose, Throat · 20d
Cleared Nov 01, 1996
RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM
K963550 · KMA
Respironics, Inc.
Ear, Nose, Throat · 57d
Cleared Oct 29, 1996
HEARSAVER
K962292 · EWD
Emtech Laboratories
Ear, Nose, Throat · 137d
Cleared Oct 28, 1996
OVATION AGC-2
K963818 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION ASP
K963819 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION LINEAR
K963820 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION AGC-1
K963821 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION AGC-3
K963822 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d