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
2425–2448 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared May 23, 1990
WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE
K897033 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 156d
Cleared May 23, 1990
MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID
K897035 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 156d
Cleared May 23, 1990
PHONAK ITE 8000, 7000, 6000 ITE HEARING AID
K900675 · ESD
Phonak, Inc.
Ear, Nose, Throat · 100d
Cleared May 23, 1990
BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC
K900829 · ESD
Phonak, Inc.
Ear, Nose, Throat · 91d
Cleared May 23, 1990
BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4
K900830 · ESD
Phonak, Inc.
Ear, Nose, Throat · 91d
Cleared May 23, 1990
BTE PICO SCD, PICO SC
K900831 · ESD
Phonak, Inc.
Ear, Nose, Throat · 91d
Cleared May 23, 1990
MODEL 366 HEARING AID
K900846 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 90d
Cleared May 23, 1990
WIDEX HEARING AID MODEL THE DISCOVERY
K901642 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 44d
Cleared May 21, 1990
SIEMENS MODEL 284 PP-L
K893573 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 284 PP-AGC
K893574 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 283 ASP
K893575 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 284 PP
K893576 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared Apr 30, 1990
DISCRETION, IN THE CANAL HEARING INSTRUMENT
K896995 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 140d
Cleared Apr 30, 1990
NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE
K897154 · ESD
Nicolet Instrument Corp.
Ear, Nose, Throat · 125d
Cleared Apr 27, 1990
VERA 103
K897143 · LYN
Madsen North America, Inc.
Ear, Nose, Throat · 121d
Cleared Apr 27, 1990
SEARS MODEL 9094 ITE HEARING AID
K901350 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Apr 27, 1990
SEARS MODEL 9098 ITE HEARING AID
K901351 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Apr 18, 1990
EXAM GLOVES (VINYL) MFG. GLORIOUS WEALTH CO.
K891556 · ESD
Green Light Import Export Co., Inc.
Ear, Nose, Throat · 397d
Cleared Apr 18, 1990
MODEL AUDINA ITE HEATING AID
K897024 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 120d
Cleared Apr 18, 1990
AUDIOTONE MODEL FFI ITE HEARING AID
K901556 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 18, 1990
BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL
K901569 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 14d
Cleared Apr 16, 1990
AHAC ITE MODEL ENTENDRE
K895843 · ESD
Aroostook Hearing Aid
Ear, Nose, Throat · 195d
Cleared Apr 16, 1990
SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT
K901387 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 16, 1990
SEARS MODEL LM9091 IN-THE-EAR HEARING INSTRUMENT
K901388 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 21d