Bivona Medical Technologies
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 50
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K952700 | SUPERSLICK | October 31, 1995 |
| K942025 | BURGET NASAL STENT | October 27, 1995 |
| K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES | October 27, 1994 |
| K935053 | BIVONA NASAL TURBINATE STENT | July 1, 1994 |
| K933398 | BIVONA ILLUMINATED ENDOTRACHEAL TUBE | October 6, 1993 |
| K931749 | BIVONA(R) ICU ENDOTRACHEAL TUBE | August 10, 1993 |
| K922665 | BIVONA HYPERFLEX TRACHEOSTOMY TUBE | January 7, 1993 |
| K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | December 29, 1992 |
| K920604 | BIVONA TRACHEAL T-TUBE STENT | July 27, 1992 |
| K915761 | BIVONA-COLORADO VOICE PROSTHESIS | June 29, 1992 |
| K915799 | BIVONA SLEEP APNEA TUBE | February 3, 1992 |
| K913859 | BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION | January 30, 1992 |
| K914183 | BIVONA CUFF MAINTENANCE DEVICE (CMD) | October 23, 1991 |
| K914088 | BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | October 23, 1991 |
| K913270 | BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | August 9, 1991 |
| K912967 | BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH. | July 17, 1991 |
| K912469 | BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE | June 19, 1991 |
| K905052 | BIVONA ENDOTRACHEAL TUBE STYLET | April 2, 1991 |
| K900583 | MODIFIED BIVONA EPISTAXIS CATHETER | August 9, 1990 |
| K901603 | MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER | May 4, 1990 |