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
1537–1560 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 30, 1995
GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)
K950730 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 134d
Cleared Jun 30, 1995
BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K
K951587 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 85d
Cleared Jun 30, 1995
FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
K951828 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 71d
Cleared Jun 28, 1995
HORTMANN AIRMATIC AIR CALORIC STIMULATOR
K950785 · KHH
Jedmed Instrument Co.
Ear, Nose, Throat · 127d
Cleared Jun 28, 1995
BELTONE COMPOSER 2000
K950868 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 121d
Cleared Jun 28, 1995
SENSICARE SYNTHETIC, SURGICAL GLOVE LINER
K950995 · LYN
Bd Becton Dickinson Vacutainer...
Ear, Nose, Throat · 117d
Cleared Jun 28, 1995
OTOSONIC (OSI) CF 10-K, 10-D
K952097 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 55d
Cleared Jun 21, 1995
MICROFLOW IRRIGATION SYSTEM
K950078 · KMA
Jedmed Instrument Co.
Ear, Nose, Throat · 162d
Cleared Jun 21, 1995
LISTENAIDER II
K952057 · LZI
National Hearing Aid Dist., Inc.
Ear, Nose, Throat · 50d
Cleared Jun 21, 1995
INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL
K952453 · ESD
Argosy Electronics
Ear, Nose, Throat · 27d
Cleared Jun 21, 1995
EXPANDER WITH ACTIVE TONE CONTROL
K952454 · ESD
Argosy Electronics
Ear, Nose, Throat · 27d
Cleared Jun 21, 1995
IMPROVED MANHATTAN II
K952455 · ESD
Argosy Electronics
Ear, Nose, Throat · 27d
Cleared Jun 19, 1995
WIDEX MODEL LOGO 32 (L32)
K952229 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 38d
Cleared Jun 16, 1995
C-FLEX ENDOLYMPHATIC SHUNT
K952227 · ESZ
Trebay Medical Corp.
Ear, Nose, Throat · 35d
Cleared Jun 16, 1995
RICHARDS PORP
K952481 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 17d
Cleared Jun 13, 1995
EAR-A-GATOR
K946108 · KHH
Life-Tech Intl., Inc.
Ear, Nose, Throat · 181d
Cleared Jun 07, 1995
HI SONIC 2000 DIGITAL HEARING INSTRUMENT
K951678 · LXB
Hearing Innovations, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 07, 1995
NASAL SEPTAL SPLINT
K952207 · LYA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 28d
Cleared Jun 05, 1995
KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION
K946332 · EQJ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 158d
Cleared Jun 05, 1995
SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE
K952228 · ESD
Resound Corp.
Ear, Nose, Throat · 25d
Cleared Jun 05, 1995
PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
K952263 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 02, 1995
NEUROSIGN 100 IMPEDANCE METER
K945799 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 186d
Cleared Jun 02, 1995
RIONET HEARING AID HM-02
K951677 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 52d
Cleared May 30, 1995
INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR...
K951896 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 36d