Bivona Medical Technologies
Mchenry, IL, US
Bivona Medical Technologies appears in FDA device records in Mchenry, IL. FDA records list 50 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 50
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 50 510(k) clearances for Bivona Medical Technologies between 1978 and 1995. The busiest year on record is 1989, with 7. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 2 |
| 1982 | 4 |
| 1983 | 1 |
| 1985 | 3 |
| 1986 | 3 |
| 1987 | 1 |
| 1988 | 3 |
| 1989 | 7 |
| 1990 | 5 |
| 1991 | 6 |
| 1992 | 5 |
| 1993 | 3 |
| 1994 | 2 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K952700 | SUPERSLICK | JOH | Substantially Equivalent | |
| K942025 | BURGET NASAL STENT | LWF | Substantially Equivalent | |
| K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES | JOH | Substantially Equivalent | |
| K935053 | BIVONA NASAL TURBINATE STENT | LYA | Substantially Equivalent | |
| K933398 | BIVONA ILLUMINATED ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | |
| K931749 | BIVONA(R) ICU ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | |
| K922665 | BIVONA HYPERFLEX TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | |
| K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | JOH | Substantially Equivalent | |
| K920604 | BIVONA TRACHEAL T-TUBE STENT | BTO | Substantially Equivalent | |
| K915761 | BIVONA-COLORADO VOICE PROSTHESIS | EWL | Substantially Equivalent | |
| K915799 | BIVONA SLEEP APNEA TUBE | BTR | Substantially Equivalent | |
| K913859 | BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION | JOH | Substantially Equivalent | |
| K914183 | BIVONA CUFF MAINTENANCE DEVICE (CMD) | JOH | Substantially Equivalent | |
| K914088 | BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | |
| K913270 | BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | |
| K912967 | BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH. | JOH | Substantially Equivalent | |
| K912469 | BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE | BTO | Substantially Equivalent | |
| K905052 | BIVONA ENDOTRACHEAL TUBE STYLET | BSR | Substantially Equivalent | |
| K900583 | MODIFIED BIVONA EPISTAXIS CATHETER | EMX | Substantially Equivalent | |
| K901603 | MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER | KOB | Substantially Equivalent | |
| K896548 | MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | |
| K896547 | MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | |
| K895946 | BIVONA CARDEN INTERMITTENT JETTING DEVICE | BTL | Substantially Equivalent | |
| K891239 | MOP CATHETER | KDL | Substantially Equivalent | |
| K894614 | BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | |
| K894613 | BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | |
| K892888 | EXTACISER PERINEAL MUSCLE EXERCISER | HIR | Substantially Equivalent | |
| K890499 | BIVONA VENTILATOR ISOLATOR SYSTEM | CAI | Substantially Equivalent | |
| K885130 | MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | |
| K885129 | MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | |
| K884427 | FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. | BTO | Substantially Equivalent | |
| K881011 | BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS | EWL | Substantially Equivalent | |
| K881744 | PORGES URETERAL STENT | FAD | Substantially Equivalent | |
| K872366 | AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | |
| K862238 | BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | |
| K862267 | FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES | BTO | Substantially Equivalent | |
| K861088 | BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS | EWL | Substantially Equivalent | |
| K853502 | VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY | BTR | Substantially Equivalent | |
| K852272 | BIVONA TRACHEOSTOMA VALVE II | BTO | Substantially Equivalent | |
| K850703 | SAF T FLO VENTILATOR TUBING | BZO | Substantially Equivalent | |
| K823749 | LOW PRESSURE BLOM-SINGER VOICE PROSTHES | EWL | Substantially Equivalent | |
| K820672 | HASSON BUEC-3 | HDP | Substantially Equivalent | |
| K821568 | BLOW-SINGER TRACHEOSTOMA VALVE | EWL | Substantially Equivalent | |
| K821584 | EPISTAXIS CATHETER/KIT | EMX | Substantially Equivalent | |
| K820737 | PERISCOPE VOICE PROSTHESIS | EWL | Substantially Equivalent | |
| K812982 | BLOM-SINGER VOICE PROSTHESIS | EWL | Substantially Equivalent | |
| K810436 | TRACHEOSTOMA VENT | BTO | Substantially Equivalent | |
| K800563 | BLOM-SINGER DUCKBILL VOICE PROSTHESIS | EWL | Substantially Equivalent | |
| K792035 | FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE | BTR | Substantially Equivalent | |
| K780583 | FOME-CUF PVC | BTR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EMXBalloon, Epistaxis
- KOBCatheter, Suprapubic (And Accessories)
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- LWFDilator, Nasal
- HDPElevator, Uterine
- HIRPerineometer
- EWLProsthesis, Laryngeal (Taub)
- KDLSet, Perfusion, Kidney, Disposable
- BZOSet, Tubing And Support, Ventilator (W Harness)
- LYASplint, Intranasal Septal
- FADStent, Ureteral
- BSRStylet, Tracheal Tube
- JOHTube Tracheostomy And Tube Cuff
- BTRTube, Tracheal (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- BTLVentilator, Emergency, Powered (Resuscitator)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain