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
1801–1824 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared May 12, 1994
THE EXPANDACELL SINUS PACK
K935724 · EMX
Denver Splint Co.
Ear, Nose, Throat · 162d
Cleared May 12, 1994
WAX GUARD OPTION
K941039 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 70d
Cleared May 12, 1994
AUDIOTONE MODEL A-54
K941121 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 64d
Cleared May 12, 1994
AUDIOTONE MODEL A-54SR
K941122 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 64d
Cleared May 12, 1994
770-ATC
K941133 · ESD
Electone, Inc.
Ear, Nose, Throat · 64d
Cleared May 12, 1994
SHARP II FULL CONTOUR
K941292 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared May 12, 1994
SHARP II SEMI CONTOUR HEARING AID
K941293 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared May 12, 1994
SHARP II LOW PROFILE HEARING AID
K941294 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared May 10, 1994
MODEL 222 CLINICAL AUDIOMETER
K934715 · EWO
Virtual Corp.
Ear, Nose, Throat · 221d
Cleared May 10, 1994
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
K935701 · LXB
Starkey Laboratories, Inc.
Ear, Nose, Throat · 161d
Cleared May 05, 1994
TYMPOVENT
K936275 · ETD
Atos Medical AB
Ear, Nose, Throat · 126d
Cleared May 04, 1994
MIRACLE-EAR WITH POWER CIRCUIT OPTION
K935962 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 142d
Cleared May 04, 1994
MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER
K940521 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 89d
Cleared May 04, 1994
155 PP AGC-I
K940608 · ESD
Danavox, Inc.
Ear, Nose, Throat · 79d
Cleared May 04, 1994
STARKEY EUROLINE A SERIES
K940978 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 64d
Cleared May 04, 1994
RIONET HEARING AID HB-54
K941021 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 62d
Cleared May 04, 1994
RIONET HEARING AID HB-37T
K941140 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 55d
Cleared May 04, 1994
FLEXIBLE GRASPING FORCEPS
K941161 · EOQ
Surgical Technologies, Inc.
Ear, Nose, Throat · 54d
Cleared May 04, 1994
BELTON MERIT (HEARING AID)
K941395 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 43d
Cleared May 04, 1994
WIDEX S-21
K941508 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 36d
Cleared May 04, 1994
INTRA S, INTRA SH
K941635 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared May 04, 1994
MINI PAK
K941636 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared May 03, 1994
COMPLETELY IN THE CANAL
K940116 · ESD
Argosy Electronics
Ear, Nose, Throat · 113d
Cleared Apr 28, 1994
FLEXIBLE BIOPSY CUP FORCEPS
K941158 · EOQ
Surgical Technologies, Inc.
Ear, Nose, Throat · 48d