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
2857–2880 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 18, 1986
PHONIC EAR, MODEL PE 1800
K862162 · ETW
Phonic Ear, Inc.
Ear, Nose, Throat · 42d
Cleared Jul 16, 1986
IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823
K862086 · ETW
A/S Bruel & Kjaer
Ear, Nose, Throat · 44d
Cleared Jul 16, 1986
INEARSET IES HEARING AID
K862222 · ESD
Inearset, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 16, 1986
HEARING AID (ALL-IN-EAR)
K862545 · ESD
Vibrasonic, Inc.
Ear, Nose, Throat · 13d
Cleared Jul 14, 1986
INCUS/STAPES PROSTHESIS
K861369 · ETB
Richards Medical Co., Inc.
Ear, Nose, Throat · 94d
Cleared Jul 14, 1986
MICROTEK INTRANASAL SPLINT
K862496 · EPP
Microtek Medical, Inc.
Ear, Nose, Throat · 13d
Cleared Jul 14, 1986
MICROTEK SEPTAL BUTTON
K862497 · LFB
Microtek Medical, Inc.
Ear, Nose, Throat · 13d
Cleared Jul 11, 1986
MICROTEK STAINLESS STEEL PISTON
K860460 · ETB
Microtek Medical, Inc.
Ear, Nose, Throat · 155d
Cleared Jun 26, 1986
MODEL CA, HEARING AID
K862095 · ESD
Fine-Tune
Ear, Nose, Throat · 24d
Cleared Jun 23, 1986
MODEL PC HEARING AID
K861939 · ESD
Fine-Tune
Ear, Nose, Throat · 34d
Cleared Jun 23, 1986
MODEL HP HEARING AID
K862036 · ESD
Fine-Tune
Ear, Nose, Throat · 25d
Cleared Jun 23, 1986
LIFESOUND CUSTOM ITE
K862050 · ESD
Lifesounds, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 23, 1986
DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID
K862099 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL ED BEHIND-THE-EAR HEARING AID
K862100 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL UM IN-THE-CANAL HEARING AID
K862101 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL KM IN-THE-CANAL HEARING AID
K862102 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL UC IN-THE-CANAL HEARING AID
K862103 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL UC SPECTRUM IN-THE-CANAL HEARING AID
K862104 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 10, 1986
WELCH ALLYN TYMPANOMETER
K861516 · ETY
Welch Allyn, Inc.
Ear, Nose, Throat · 48d
Cleared Jun 09, 1986
PHONIC EAR
K861857 · ETW
Phonic Ear, Inc.
Ear, Nose, Throat · 26d
Cleared Jun 05, 1986
RX-33S INTRA MINI CANAL MODULE
K861532 · ESD
Rexton, Inc.
Ear, Nose, Throat · 42d
Cleared Jun 02, 1986
BEHING-THE-EAR HEARING AID SERIES SP
K861597 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 34d
Cleared May 30, 1986
TYPE 6500 HEARING AID ANALYZER
K861571 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 32d
Cleared May 30, 1986
XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
K861971 · LXB
Xomed, Inc.
Ear, Nose, Throat · 9d