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
1873–1896 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 21, 1994
NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID
K935330 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID
K935331 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR AE-1 IN THE EAR (ITE) HEARING AID
K935332 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SS-1 IN THE EAR (ITE) HEARING AID
K935333 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SD-1 IN THE EAR (ITE) HEARING AID
K935334 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID
K935335 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 14, 1994
FONIX 3500 HEARING AID ANALYZER
K935400 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 66d
Cleared Jan 13, 1994
BINAURAL HEARING AID
K935366 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 70d
Cleared Jan 05, 1994
XOMED-TREACE RIGID ROD LENS ENDOSCOPE
K933105 · EOB
Xomed-Treace, Inc.
Ear, Nose, Throat · 194d
Cleared Jan 05, 1994
AUDIPHON, MODEL H-11
K935458 · ESD
National Hearing Aid Dist., Inc.
Ear, Nose, Throat · 54d
Cleared Dec 27, 1993
MICRO-TECH TRU CANAL
K934149 · ESD
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 125d
Cleared Dec 22, 1993
PRO FIT-CYBER II OPTION
K935289 · ESD
Qualitone
Ear, Nose, Throat · 49d
Cleared Dec 15, 1993
BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET
K932163 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 225d
Cleared Dec 15, 1993
CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE
K932259 · ERA
Clarus Medical Systems, Inc.
Ear, Nose, Throat · 239d
Cleared Dec 15, 1993
PAL (PERSONAL AMPLIFIER FOR LISTENING)
K933963 · ESD
Hearing Care Products, Inc.
Ear, Nose, Throat · 121d
Cleared Dec 15, 1993
8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS
K935095 · ESD
3M Company
Ear, Nose, Throat · 51d
Cleared Dec 15, 1993
MIRACLE EAR MODEL SHARP II CANAL
K935265 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 15, 1993
MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID
K935266 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 15, 1993
SOUNDRIGHT, SHP
K935420 · ESD
Soundright Hearing Products
Ear, Nose, Throat · 36d
Cleared Dec 02, 1993
BIOSIL MEDICAL GRADE SILICONE SHEETING
K932176 · KHJ
Bioplexus Corp.
Ear, Nose, Throat · 211d
Cleared Nov 29, 1993
OMNI 2000 SERIES ITE HEARING AID
K934416 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 77d
Cleared Nov 29, 1993
OMNI 2000 SERIES ITC HEARING AID
K934417 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 77d
Cleared Nov 29, 1993
UNITRON MODEL IKON AGCO/ AOD
K934565 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 74d
Cleared Nov 24, 1993
SELECTOR SL 01
K933220 · EWO
Futuremed Div. of Future Impex Corp.
Ear, Nose, Throat · 146d