Medical Device Manufacturer · US , Mchenry , IL

Bivona Medical Technologies - FDA 510(k) Cleared Devices

50 submissions · 50 cleared · Since 1978
50
Total
50
Cleared
0
Denied
50 devices
26-50 of 50
Cleared Oct 13, 1989
BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K894614 · JOH
Anesthesiology · 85d
Cleared Oct 05, 1989
EXTACISER PERINEAL MUSCLE EXERCISER
K892888 · HIR
Gastroenterology & Urology · 168d
Cleared Jun 15, 1989
BIVONA VENTILATOR ISOLATOR SYSTEM
K890499 · CAI
Anesthesiology · 134d
Cleared Feb 27, 1989
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K885129 · JOH
Anesthesiology · 77d
Cleared Feb 27, 1989
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K885130 · JOH
Anesthesiology · 77d
Cleared Nov 02, 1988
FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.
K884427 · BTO
Anesthesiology · 13d
Cleared May 13, 1988
BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS
K881011 · EWL
Ear, Nose, Throat · 64d
Cleared May 03, 1988
PORGES URETERAL STENT
K881744 · FAD
Gastroenterology & Urology · 11d
Cleared Aug 17, 1987
AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE
K872366 · BTR
Anesthesiology · 60d
Cleared Oct 15, 1986
BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE
K862238 · BTR
Anesthesiology · 125d
Cleared Jun 18, 1986
FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES
K862267 · BTO
Anesthesiology · 5d
Cleared Apr 02, 1986
BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS
K861088 · EWL
Ear, Nose, Throat · 12d
Cleared Oct 01, 1985
VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY
K853502 · BTR
Anesthesiology · 41d
Cleared Jul 08, 1985
BIVONA TRACHEOSTOMA VALVE II
K852272 · BTO
Anesthesiology · 41d
Cleared Mar 25, 1985
SAF T FLO VENTILATOR TUBING
K850703 · BZO
Anesthesiology · 32d
Cleared Jan 07, 1983
LOW PRESSURE BLOM-SINGER VOICE PROSTHES
K823749 · EWL
Ear, Nose, Throat · 25d
Cleared Jul 30, 1982
HASSON BUEC-3
K820672 · HDP
Obstetrics & Gynecology · 141d
Cleared Jul 26, 1982
BLOW-SINGER TRACHEOSTOMA VALVE
K821568 · EWL
Ear, Nose, Throat · 60d
Cleared Jun 14, 1982
EPISTAXIS CATHETER/KIT
K821584 · EMX
Ear, Nose, Throat · 13d
Cleared Apr 09, 1982
PERISCOPE VOICE PROSTHESIS
K820737 · EWL
Ear, Nose, Throat · 22d
Cleared Nov 24, 1981
BLOM-SINGER VOICE PROSTHESIS
K812982 · EWL
Ear, Nose, Throat · 32d
Cleared Mar 04, 1981
TRACHEOSTOMA VENT
K810436 · BTO
Anesthesiology · 13d
Cleared Mar 25, 1980
BLOM-SINGER DUCKBILL VOICE PROSTHESIS
K800563 · EWL
Ear, Nose, Throat · 12d
Cleared Oct 26, 1979
FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE
K792035 · BTR
Anesthesiology · 16d
Cleared May 12, 1978
FOME-CUF PVC
K780583 · BTR
Anesthesiology · 30d
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