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
1897–1920 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Nov 22, 1993
PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS
K933247 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 143d
Cleared Nov 19, 1993
ORBITER 922 CLINICAL AUDIOMETER
K931324 · EWO
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 248d
Cleared Nov 19, 1993
R AND D BATTERIES, INC. PART NOS. 5038 & 5347
K933491 · ETN
R & D Batteries, Inc.
Ear, Nose, Throat · 127d
Cleared Nov 19, 1993
CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST
K934193 · EOX
Biosearch Medical Products, Inc.
Ear, Nose, Throat · 85d
Cleared Nov 19, 1993
RIONET HEARING AID HA-72
K934479 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 70d
Cleared Nov 19, 1993
RIONET HEARING AID HA-73
K934480 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 70d
Cleared Nov 19, 1993
PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID
K934586 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 57d
Cleared Nov 19, 1993
CLARIFIER II CIRCUIT OPTION
K934597 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared Nov 19, 1993
OTOSONIC ADVANCED FULL SHIELD (AFS)
K934618 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 53d
Cleared Nov 03, 1993
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K931372 · ESD
Resound Corp.
Ear, Nose, Throat · 231d