Bivona Medical Technologies - FDA 510(k) Cleared Devices
50
Total
50
Cleared
0
Denied
12 devices
Cleared
Oct 27, 1995
BURGET NASAL STENT
Ear, Nose, Throat
549d
Cleared
Jul 01, 1994
BIVONA NASAL TURBINATE STENT
Ear, Nose, Throat
253d
Cleared
Jun 29, 1992
BIVONA-COLORADO VOICE PROSTHESIS
Ear, Nose, Throat
188d
Cleared
Aug 09, 1990
MODIFIED BIVONA EPISTAXIS CATHETER
Ear, Nose, Throat
183d
Cleared
May 13, 1988
BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS
Ear, Nose, Throat
64d
Cleared
Apr 02, 1986
BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS
Ear, Nose, Throat
12d
Cleared
Jan 07, 1983
LOW PRESSURE BLOM-SINGER VOICE PROSTHES
Ear, Nose, Throat
25d
Cleared
Jul 26, 1982
BLOW-SINGER TRACHEOSTOMA VALVE
Ear, Nose, Throat
60d
Cleared
Jun 14, 1982
EPISTAXIS CATHETER/KIT
Ear, Nose, Throat
13d
Cleared
Apr 09, 1982
PERISCOPE VOICE PROSTHESIS
Ear, Nose, Throat
22d
Cleared
Nov 24, 1981
BLOM-SINGER VOICE PROSTHESIS
Ear, Nose, Throat
32d
Cleared
Mar 25, 1980
BLOM-SINGER DUCKBILL VOICE PROSTHESIS
Ear, Nose, Throat
12d