| SUPERSLICK (K952700) | Bivona Medical Technologies | 1995-10-31 |
| BURGET NASAL STENT (K942025) | Bivona Medical Technologies | 1995-10-27 |
| BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES (K944178) | Bivona Medical Technologies | 1994-10-27 |
| BIVONA NASAL TURBINATE STENT (K935053) | Bivona Medical Technologies | 1994-07-01 |
| BIVONA ILLUMINATED ENDOTRACHEAL TUBE (K933398) | Bivona Medical Technologies | 1993-10-06 |
| BIVONA(R) ICU ENDOTRACHEAL TUBE (K931749) | Bivona Medical Technologies | 1993-08-10 |
| BIVONA HYPERFLEX TRACHEOSTOMY TUBE (K922665) | Bivona Medical Technologies | 1993-01-07 |
| BIVONA CUSTOMIZED TRACHEOSTOMY TUBES (K923878) | Bivona Medical Technologies | 1992-12-29 |
| BIVONA TRACHEAL T-TUBE STENT (K920604) | Bivona Medical Technologies | 1992-07-27 |
| BIVONA-COLORADO VOICE PROSTHESIS (K915761) | Bivona Medical Technologies | 1992-06-29 |
| BIVONA SLEEP APNEA TUBE (K915799) | Bivona Medical Technologies | 1992-02-03 |
| BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION (K913859) | Bivona Medical Technologies | 1992-01-30 |
| BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE (K914088) | Bivona Medical Technologies | 1991-10-23 |
| BIVONA CUFF MAINTENANCE DEVICE (CMD) (K914183) | Bivona Medical Technologies | 1991-10-23 |
| BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE (K913270) | Bivona Medical Technologies | 1991-08-09 |
| BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH. (K912967) | Bivona Medical Technologies | 1991-07-17 |
| BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE (K912469) | Bivona Medical Technologies | 1991-06-19 |
| BIVONA ENDOTRACHEAL TUBE STYLET (K905052) | Bivona Medical Technologies | 1991-04-02 |
| MODIFIED BIVONA EPISTAXIS CATHETER (K900583) | Bivona Medical Technologies | 1990-08-09 |
| MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER (K901603) | Bivona Medical Technologies | 1990-05-04 |
| MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE (K896547) | Bivona Medical Technologies | 1990-01-22 |
| MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE (K896548) | Bivona Medical Technologies | 1990-01-22 |
| BIVONA CARDEN INTERMITTENT JETTING DEVICE (K895946) | Bivona Medical Technologies | 1990-01-09 |
| MOP CATHETER (K891239) | Bivona Medical Technologies | 1989-11-28 |
| BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE (K894613) | Bivona Medical Technologies | 1989-10-13 |
| BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE (K894614) | Bivona Medical Technologies | 1989-10-13 |
| EXTACISER PERINEAL MUSCLE EXERCISER (K892888) | Bivona Medical Technologies | 1989-10-05 |
| BIVONA VENTILATOR ISOLATOR SYSTEM (K890499) | Bivona Medical Technologies | 1989-06-15 |
| MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE (K885129) | Bivona Medical Technologies | 1989-02-27 |
| MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE (K885130) | Bivona Medical Technologies | 1989-02-27 |
| FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. (K884427) | Bivona Medical Technologies | 1988-11-02 |
| BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS (K881011) | Bivona Medical Technologies | 1988-05-13 |
| PORGES URETERAL STENT (K881744) | Bivona Medical Technologies | 1988-05-03 |
| AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE (K872366) | Bivona Medical Technologies | 1987-08-17 |
| BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE (K862238) | Bivona Medical Technologies | 1986-10-15 |
| FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES (K862267) | Bivona Medical Technologies | 1986-06-18 |
| BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS (K861088) | Bivona Medical Technologies | 1986-04-02 |
| VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY (K853502) | Bivona Medical Technologies | 1985-10-01 |
| BIVONA TRACHEOSTOMA VALVE II (K852272) | Bivona Medical Technologies | 1985-07-08 |
| SAF T FLO VENTILATOR TUBING (K850703) | Bivona Medical Technologies | 1985-03-25 |
| LOW PRESSURE BLOM-SINGER VOICE PROSTHES (K823749) | Bivona Medical Technologies | 1983-01-07 |
| HASSON BUEC-3 (K820672) | Bivona Medical Technologies | 1982-07-30 |
| BLOW-SINGER TRACHEOSTOMA VALVE (K821568) | Bivona Medical Technologies | 1982-07-26 |
| EPISTAXIS CATHETER/KIT (K821584) | Bivona Medical Technologies | 1982-06-14 |
| PERISCOPE VOICE PROSTHESIS (K820737) | Bivona Medical Technologies | 1982-04-09 |
| BLOM-SINGER VOICE PROSTHESIS (K812982) | Bivona Medical Technologies | 1981-11-24 |
| TRACHEOSTOMA VENT (K810436) | Bivona Medical Technologies | 1981-03-04 |
| BLOM-SINGER DUCKBILL VOICE PROSTHESIS (K800563) | Bivona Medical Technologies | 1980-03-25 |
| FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE (K792035) | Bivona Medical Technologies | 1979-10-26 |
| FOME-CUF PVC (K780583) | Bivona Medical Technologies | 1978-05-12 |