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
2521–2544 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Oct 24, 1989
3M INSTANT FIT CUSTOM EARMOLD
K895134 · ESD
3M Company
Ear, Nose, Throat · 69d
Cleared Oct 12, 1989
AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
K890993 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 227d
Cleared Oct 12, 1989
AMPLAID A308 CLINICAL AUDIOMETER
K891988 · EWO
Amplus Corp.
Ear, Nose, Throat · 198d
Cleared Oct 12, 1989
APDYNE PHENOL APPLICATOR KIT
K894369 · KCJ
Apdyne Medical Co.
Ear, Nose, Throat · 90d
Cleared Oct 11, 1989
CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54
K895140 · ESD
Oticon Corp.
Ear, Nose, Throat · 56d
Cleared Sep 27, 1989
HEARING AID (IN-THE-CANAL)
K894414 · ESD
Hearing Aid Express
Ear, Nose, Throat · 72d
Cleared Sep 21, 1989
RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE
K894019 · KHL
Resound Corp.
Ear, Nose, Throat · 107d
Cleared Sep 08, 1989
LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT
K893721 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 114d
Cleared Sep 08, 1989
LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT
K893722 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 114d
Cleared Sep 08, 1989
LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT
K893723 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 114d
Cleared Aug 21, 1989
BIOMETER AUDIOMETER
K883505 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 369d
Cleared Aug 21, 1989
AUDITORY TRAINER PE150R FM RECEIVER
K893431 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 111d
Cleared Aug 15, 1989
OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID
K893528 · ESD
Oticon Corp.
Ear, Nose, Throat · 99d
Cleared Aug 08, 1989
ASTRO BEHIND-THE-EAR HEARING AID
K892898 · ESD
Rexton, Inc.
Ear, Nose, Throat · 110d
Cleared Aug 04, 1989
PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II
K893432 · ESD
Electone, Inc.
Ear, Nose, Throat · 94d
Cleared Aug 04, 1989
RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3
K893927 · ESD
Resound Corp.
Ear, Nose, Throat · 65d
Cleared Aug 03, 1989
BEHIND-THE-EAR HEARING AID MODEL 48 AGCI
K892338 · ESD
Qualitone
Ear, Nose, Throat · 120d
Cleared Aug 03, 1989
APACERAM OSSICULAR PROSTHESIS
K893134 · ETB
Asahi Optical Co. C/O Rosati...
Ear, Nose, Throat · 100d
Cleared Jul 14, 1989
ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER
K890124 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 184d
Cleared Jul 14, 1989
TRACOR RA500 AUDIOMETER
K891373 · EWO
Tracor Instruments Austin, Inc.
Ear, Nose, Throat · 127d
Cleared Jul 14, 1989
ITE PRESCRIPTION SERIES MODEL LP
K891915 · ESD
Us Hearing Centers, Inc.
Ear, Nose, Throat · 109d
Cleared Jul 14, 1989
ITE PRESCRIPTION SERIES MODEL PP + F
K891916 · ESD
Us Hearing Centers, Inc.
Ear, Nose, Throat · 109d
Cleared Jun 22, 1989
'EXMOOR' SINGLE USE SUCTION TUBE
K892504 · LRC
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 72d
Cleared Jun 22, 1989
PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911
K892803 · ESD
United Hearing Systems, Inc.
Ear, Nose, Throat · 66d