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
3529–3552 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 04, 1980
OMNITON MT80-A BODY HEARING AID
K800779 · ESD
Bosch Hearing Instruments, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 04, 1980
AUDIONICS PB MAX HEARING AID
K800940 · ESD
Audionics Corp.
Ear, Nose, Throat · 43d
Cleared Jun 04, 1980
BEHIND-THE-EAR HEARING AID SERIES G
K801062 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 29d
Cleared May 28, 1980
OTICON EARETTE HEARING AID #E17 HC
K801002 · ESD
Oticon Corp.
Ear, Nose, Throat · 30d
Cleared May 28, 1980
OTICON EARETTE HEARING AID #E17CF
K801003 · ESD
Oticon Corp.
Ear, Nose, Throat · 30d
Cleared May 28, 1980
ASL CUSTOM IN-THE-EAR HEARING AID #L
K801023 · ESD
American Sound Labs
Ear, Nose, Throat · 27d
Cleared May 28, 1980
TELESONIC, SOUNDEX & GENERIC V-101
K801066 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 22d
Cleared May 28, 1980
TELESONIC, GENERIC & SOUNDEX C-102
K801067 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 22d
Cleared May 28, 1980
DAHLBERG HEARING AID MODEL MEH
K801114 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 16d
Cleared May 28, 1980
DAHLBERG HEARING AID MODEL MEL
K801115 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 16d
Cleared May 28, 1980
FIBER OPTIC LIGHT SOURCE
K801176 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 12d
Cleared May 08, 1980
TA-641 TINNITUS INSTRUMENT
K800702 · KLW
Audiotrone
Ear, Nose, Throat · 41d
Cleared May 08, 1980
RADIOEAR MODEL REI HEARING AID
K800945 · ESD
Radioear Corp.
Ear, Nose, Throat · 16d
Cleared Apr 29, 1980
RADIOEAR MODEL RM-L & RM-C HEARING AID
K800567 · ESD
Radioear Corp.
Ear, Nose, Throat · 47d
Cleared Apr 29, 1980
MINUET MASKER
K800784 · KLW
Beltone Electronics Corp.
Ear, Nose, Throat · 21d
Cleared Apr 24, 1980
JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE
K800623 · KCD
Pilling Co.
Ear, Nose, Throat · 36d
Cleared Apr 24, 1980
RIONET &/OR RION HEARING AID MOD. HB-67S
K800738 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 24, 1980
RIONET &/OR RION HEARING AID MODEL HA-82
K800739 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 21, 1980
FELDMAN MINI-SAW, #300000
K800669 · EWQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 26d
Cleared Apr 16, 1980
GOODE T-TUBE, BIOLITE COATED SILICONE/TU
K800727 · ETD
Xomed, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 16, 1980
PAPARELL TYPE 2, BIOLITE COATED SILI-
K800728 · ETD
Xomed, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 16, 1980
DUNRICH TABLES
K800756 · ETF
Dunrich, Inc.
Ear, Nose, Throat · 12d
Cleared Apr 10, 1980
T-570 TINNITUS MASKER
K800701 · KLW
Audiotrone
Ear, Nose, Throat · 13d
Cleared Apr 08, 1980
SEARS ALL-IN-THE-EAR HEARING AID #8149
K800446 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 40d