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
2449–2472 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Apr 10, 1990
WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL
K901316 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 20d
Cleared Apr 10, 1990
WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL
K901317 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 20d
Cleared Apr 04, 1990
HEARING AID (ALL-IN-THE-EAR)
K900789 · ESD
Solar Aid Corp.
Ear, Nose, Throat · 43d
Cleared Apr 04, 1990
DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT
K900861 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d
Cleared Mar 27, 1990
DENTEC 4000
K894930 · ETN
Dentec, Inc.
Ear, Nose, Throat · 237d
Cleared Mar 27, 1990
BRACKMANN EMG MONITORING SYSTEM
K895838 · ETN
Wr Medical Electronics Co.
Ear, Nose, Throat · 176d
Cleared Mar 27, 1990
PORT-O-SCOPE(TM)
K895948 · EOQ
North American Medical Products, Inc.
Ear, Nose, Throat · 168d
Cleared Mar 27, 1990
MICROMATE 304
K896401 · EWO
Madsen North America, Inc.
Ear, Nose, Throat · 140d
Cleared Mar 27, 1990
REXTON PP 142, PP 142-L
K900636 · ESD
Rexton, Inc.
Ear, Nose, Throat · 46d
Cleared Mar 16, 1990
OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID
K897023 · LRB
Audina Hearing Instrument
Ear, Nose, Throat · 87d
Cleared Mar 16, 1990
GIBSON ENDOLYMPHATIC SHUNT
K897049 · ESZ
Hood Laboratories
Ear, Nose, Throat · 88d
Cleared Mar 15, 1990
WIDEX HEARING AID MODELS ES9T AND ES9H
K895981 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 154d
Cleared Mar 15, 1990
WIDEX HEARING AID MODEL ES 10 ASP T
K895982 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 154d
Cleared Mar 14, 1990
HEARING AID (ALL-IN-THE-EAR)
K893004 · ESD
Hearing Specialists of Nevada, Inc.
Ear, Nose, Throat · 324d