Company ยท US
Bivona Medical Technologies
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1995. Name variants (Inc, Corp, punctuation) are merged.
50510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | 15 |
| BTR | Tube, Tracheal (W/Wo Connector) | 8 |
| EWL | Prosthesis, Laryngeal (Taub) | 8 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 6 |
| EMX | Balloon, Epistaxis | 2 |
| BSR | Stylet, Tracheal Tube | 1 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
| FAD | Stent, Ureteral | 1 |
| HDP | Elevator, Uterine | 1 |
| HIR | Perineometer | 1 |
| KDL | Set, Perfusion, Kidney, Disposable | 1 |
| KOB | Catheter, Suprapubic (And Accessories) | 1 |
| LWF | Dilator, Nasal | 1 |
| LYA | Splint, Intranasal Septal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 31, 1995 | K952700 | SUPERSLICK Bivona Medical Technologies | JOH |
| Oct 27, 1995 | K942025 | BURGET NASAL STENT Bivona Medical Technologies | LWF |
| Oct 27, 1994 | K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES Bivona Medical Technologies | JOH |
| Jul 1, 1994 | K935053 | BIVONA NASAL TURBINATE STENT Bivona Medical Technologies | LYA |
| Oct 6, 1993 | K933398 | BIVONA ILLUMINATED ENDOTRACHEAL TUBE Bivona Medical Technologies | BTR |
| Aug 10, 1993 | K931749 | BIVONA(R) ICU ENDOTRACHEAL TUBE Bivona Medical Technologies | BTR |
| Jan 7, 1993 | K922665 | BIVONA HYPERFLEX TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
| Dec 29, 1992 | K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES Bivona Medical Technologies | JOH |
| Jul 27, 1992 | K920604 | BIVONA TRACHEAL T-TUBE STENT Bivona Medical Technologies | BTO |
| Jun 29, 1992 | K915761 | BIVONA-COLORADO VOICE PROSTHESIS Bivona Medical Technologies | EWL |
| Feb 3, 1992 | K915799 | BIVONA SLEEP APNEA TUBE Bivona Medical Technologies | BTR |
| Jan 30, 1992 | K913859 | BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION Bivona Medical Technologies | JOH |
| Oct 23, 1991 | K914183 | BIVONA CUFF MAINTENANCE DEVICE (CMD) Bivona Medical Technologies | JOH |
| Oct 23, 1991 | K914088 | BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
| Aug 9, 1991 | K913270 | BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
| Jul 17, 1991 | K912967 | BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH. Bivona Medical Technologies | JOH |
| Jun 19, 1991 | K912469 | BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE Bivona Medical Technologies | BTO |
| Apr 2, 1991 | K905052 | BIVONA ENDOTRACHEAL TUBE STYLET Bivona Medical Technologies | BSR |
| Aug 9, 1990 | K900583 | MODIFIED BIVONA EPISTAXIS CATHETER Bivona Medical Technologies | EMX |
| May 4, 1990 | K901603 | MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER Bivona Medical Technologies | KOB |
| Jan 22, 1990 | K896548 | MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
| Jan 22, 1990 | K896547 | MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
| Jan 9, 1990 | K895946 | BIVONA CARDEN INTERMITTENT JETTING DEVICE Bivona Medical Technologies | BTL |
| Nov 28, 1989 | K891239 | MOP CATHETER Bivona Medical Technologies | KDL |
| Oct 13, 1989 | K894614 | BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
| Oct 13, 1989 | K894613 | BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
| Oct 5, 1989 | K892888 | EXTACISER PERINEAL MUSCLE EXERCISER Bivona Medical Technologies | HIR |
| Jun 15, 1989 | K890499 | BIVONA VENTILATOR ISOLATOR SYSTEM Bivona Medical Technologies | CAI |
| Feb 27, 1989 | K885130 | MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
| Feb 27, 1989 | K885129 | MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
| Nov 2, 1988 | K884427 | FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. Bivona Medical Technologies | BTO |
| May 13, 1988 | K881011 | BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS Bivona Medical Technologies | EWL |
| May 3, 1988 | K881744 | PORGES URETERAL STENT Bivona Medical Technologies | FAD |
| Aug 17, 1987 | K872366 | AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE Bivona Medical Technologies | BTR |
| Oct 15, 1986 | K862238 | BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE Bivona Medical Technologies | BTR |
| Jun 18, 1986 | K862267 | FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES Bivona Medical Technologies | BTO |
| Apr 2, 1986 | K861088 | BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS Bivona Medical Technologies | EWL |
| Oct 1, 1985 | K853502 | VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY Bivona Medical Technologies | BTR |
| Jul 8, 1985 | K852272 | BIVONA TRACHEOSTOMA VALVE II Bivona Medical Technologies | BTO |
| Mar 25, 1985 | K850703 | SAF T FLO VENTILATOR TUBING Bivona Medical Technologies | BZO |
| Jan 7, 1983 | K823749 | LOW PRESSURE BLOM-SINGER VOICE PROSTHES Bivona Medical Technologies | EWL |
| Jul 30, 1982 | K820672 | HASSON BUEC-3 Bivona Medical Technologies | HDP |
| Jul 26, 1982 | K821568 | BLOW-SINGER TRACHEOSTOMA VALVE Bivona Medical Technologies | EWL |
| Jun 14, 1982 | K821584 | EPISTAXIS CATHETER/KIT Bivona Medical Technologies | EMX |
| Apr 9, 1982 | K820737 | PERISCOPE VOICE PROSTHESIS Bivona Medical Technologies | EWL |
| Nov 24, 1981 | K812982 | BLOM-SINGER VOICE PROSTHESIS Bivona Medical Technologies | EWL |
| Mar 4, 1981 | K810436 | TRACHEOSTOMA VENT Bivona Medical Technologies | BTO |
| Mar 25, 1980 | K800563 | BLOM-SINGER DUCKBILL VOICE PROSTHESIS Bivona Medical Technologies | EWL |
| Oct 26, 1979 | K792035 | FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE Bivona Medical Technologies | BTR |
| May 12, 1978 | K780583 | FOME-CUF PVC Bivona Medical Technologies | BTR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||