General Hearing Instruments, Inc. is one of 14511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
General Hearing Instruments, Inc. - FDA 510(k) Cleared Devices
Recent clearances: TRANQUIL TRI-BTE, TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC, AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
5
Total
5
Cleared
0
Denied
General Hearing Instruments, Inc. has 5 FDA 510(k) cleared medical devices. Based in Roanoke, US.
Historical record: 5 cleared submissions from 1985 to 2006. Primary specialty: Ear, Nose, Throat.
Browse the FDA 510(k) cleared devices submitted by General Hearing Instruments, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - General Hearing Instruments, Inc.
5 devices
Cleared
Jun 30, 2006
TRANQUIL TRI-BTE
Ear, Nose, Throat
35d
Cleared
Mar 06, 1998
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
Ear, Nose, Throat
77d
Cleared
Jun 13, 1997
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
Ear, Nose, Throat
59d
Cleared
Jul 20, 1994
AURIS CIC
Ear, Nose, Throat
21d
Cleared
Mar 21, 1985
IN-TH-EAR HEARING AID
Ear, Nose, Throat
66d