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
2449–2472 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared May 21, 1990
SIEMENS MODEL 283 ASP
K893575 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 284 PP
K893576 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared Apr 30, 1990
DISCRETION, IN THE CANAL HEARING INSTRUMENT
K896995 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 140d
Cleared Apr 30, 1990
NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE
K897154 · ESD
Nicolet Instrument Corp.
Ear, Nose, Throat · 125d
Cleared Apr 27, 1990
VERA 103
K897143 · LYN
Madsen North America, Inc.
Ear, Nose, Throat · 121d
Cleared Apr 27, 1990
SEARS MODEL 9094 ITE HEARING AID
K901350 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Apr 27, 1990
SEARS MODEL 9098 ITE HEARING AID
K901351 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Apr 18, 1990
EXAM GLOVES (VINYL) MFG. GLORIOUS WEALTH CO.
K891556 · ESD
Green Light Import Export Co., Inc.
Ear, Nose, Throat · 397d
Cleared Apr 18, 1990
MODEL AUDINA ITE HEATING AID
K897024 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 120d
Cleared Apr 18, 1990
AUDIOTONE MODEL FFI ITE HEARING AID
K901556 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 18, 1990
BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL
K901569 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 14d
Cleared Apr 16, 1990
AHAC ITE MODEL ENTENDRE
K895843 · ESD
Aroostook Hearing Aid
Ear, Nose, Throat · 195d
Cleared Apr 16, 1990
SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT
K901387 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 16, 1990
SEARS MODEL LM9091 IN-THE-EAR HEARING INSTRUMENT
K901388 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 16, 1990
SEARS MODEL LC9092 IN-THE-EAR HEARING INSTRUMENT
K901389 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 16, 1990
SEARS MODEL LF9096 IN-THE-EAR HEARING INSTRUMENT
K901469 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 20d
Cleared Apr 16, 1990
SEARS MODEL JCS IN-THE-EAR HEARING INSTRUMENT
K901470 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 20d
Cleared Apr 13, 1990
INNOVATIONS NASAL TAMPON
K896248 · EMX
Innovations by Necessity, Inc.
Ear, Nose, Throat · 165d
Cleared Apr 13, 1990
MIDIMATE 622
K896710 · EWO
Madsen North America, Inc.
Ear, Nose, Throat · 136d
Cleared Apr 13, 1990
DAHLBERG MODEL JM IN-THE-EAR HEARING INSTRUMENT
K900862 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 49d
Cleared Apr 13, 1990
SEARS MODEL LS9093 IN-THE-EAR HEARING INSTRUMENT
K901386 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 18d
Cleared Apr 10, 1990
ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES
K900176 · EOB
Machida, Inc.
Ear, Nose, Throat · 88d
Cleared Apr 10, 1990
HEARING AID (ALL-IN-THE-EAR)
K900968 · ESD
Audiology of Tulsa, Inc.
Ear, Nose, Throat · 39d
Cleared Apr 10, 1990
OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44
K901292 · ESD
Oticon Corp.
Ear, Nose, Throat · 21d