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
1513–1536 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 10, 1995
WELCH ALLY OTOSCOPE
K952578 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 06, 1995
GSI 65 COMPUTERIZED AUDIOMETER
K951759 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 80d
Cleared Jul 06, 1995
WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL
K952450 · ESD
Argosy Electronics
Ear, Nose, Throat · 42d
Cleared Jul 06, 1995
CLASS D LINEAR WITH ACTIVE TONE CONTROL
K952451 · ESD
Argosy Electronics
Ear, Nose, Throat · 42d
Cleared Jul 06, 1995
OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL
K952452 · ESD
Argosy Electronics
Ear, Nose, Throat · 42d
Cleared Jul 03, 1995
ACUTEK'S CLEARPASSAGE
K951644 · LWF
Acutek Adhesive Specialties, Inc.
Ear, Nose, Throat · 84d
Cleared Jul 03, 1995
KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING
K952081 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 61d
Cleared Jul 03, 1995
RICHARDS TORP
K952549 · ETA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 31d
Cleared Jul 03, 1995
LORI-A
K952711 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 19d
Cleared Jun 30, 1995
ACURA-EX
K946232 · ESD
Lustgarten Multi-Tech Intl.
Ear, Nose, Throat · 190d
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