Medical Device Manufacturer · US , Mchenry , IL

Bivona Medical Technologies - FDA 510(k) Cleared Devices

50 submissions · 50 cleared · Since 1978

Recent clearances: SUPERSLICK, BURGET NASAL STENT, BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES

50

Total

50

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bivona Medical Technologies Anesthesiology ✕

33 devices

1-12 of 33

Cleared Oct 31, 1995

Anesthesiology · 140d

Cleared Oct 27, 1994

BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES

Anesthesiology · 62d

Cleared Oct 06, 1993

BIVONA ILLUMINATED ENDOTRACHEAL TUBE

Anesthesiology · 86d

Cleared Aug 10, 1993

BIVONA(R) ICU ENDOTRACHEAL TUBE

Anesthesiology · 124d

Cleared Jan 07, 1993

BIVONA HYPERFLEX TRACHEOSTOMY TUBE

Anesthesiology · 220d

Cleared Dec 29, 1992

BIVONA CUSTOMIZED TRACHEOSTOMY TUBES

Anesthesiology · 148d

Cleared Jul 27, 1992

BIVONA TRACHEAL T-TUBE STENT

Anesthesiology · 167d

Cleared Feb 03, 1992

BIVONA SLEEP APNEA TUBE

Anesthesiology · 41d

Cleared Jan 30, 1992

BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION

Anesthesiology · 156d

Cleared Oct 23, 1991

BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE

Anesthesiology · 42d

Cleared Oct 23, 1991

BIVONA CUFF MAINTENANCE DEVICE (CMD)

Anesthesiology · 35d

Cleared Aug 09, 1991

BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE

Anesthesiology · 17d