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
2473–2496 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Mar 14, 1990
MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID
K900050 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 70d
Cleared Mar 14, 1990
DAHLBERG MODEL JMS IN-THE-EAR HEARING INSTRUMENT
K900692 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 29d
Cleared Mar 09, 1990
BIOPSY FORCEPS, (NON-RIGID)
K896146 · EOQ
Portlyn Corp.
Ear, Nose, Throat · 137d
Cleared Mar 05, 1990
EXMOOR BITE BUFFER
K893006 · EOQ
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 315d
Cleared Mar 05, 1990
IN THE EAR HEARING AID
K895368 · ESD
Hearing Crafters of America
Ear, Nose, Throat · 188d
Cleared Mar 05, 1990
MD5 AUTOMATIC AUDIOMETER
K896909 · EWO
Singer Medical Products, Inc.
Ear, Nose, Throat · 84d
Cleared Feb 22, 1990
LORENZ STENT
K896667 · FWN
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 87d
Cleared Feb 22, 1990
MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID
K900237 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 36d
Cleared Feb 22, 1990
MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID
K900238 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 36d
Cleared Feb 08, 1990
RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA1
K896463 · ESD
Resound Corp.
Ear, Nose, Throat · 87d