Care Fusion
Waukegan, IL, US
Care Fusion appears in FDA device records in Waukegan, IL. FDA records list 34 510(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
- 34
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 34 510(k) clearances for Care Fusion between 2010 and 2024. The busiest year on record is 2023, with 6. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 5 |
| 2013 | 4 |
| 2014 | 3 |
| 2015 | 4 |
| 2016 | 3 |
| 2017 | 3 |
| 2020 | 1 |
| 2023 | 6 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233021 | BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device | LHI | Substantially Equivalent | |
| K231888 | BD Texium™ Needle-Free Syringe | FMF | Substantially Equivalent | |
| K221327 | BD Alaris™ Pump Infusion Sets | FPA | Substantially Equivalent | |
| K221319 | BD Alaris™ Pump Epidural Infusion Set | PWH | Substantially Equivalent | |
| K223101 | BD Secondary Infusion Set | FPA | Substantially Equivalent | |
| K223088 | BD SmartSite™ Needle-Free Connector | FPA | Substantially Equivalent | |
| K223076 | BD Texium™ Closed Male Luer | ONB | Substantially Equivalent | |
| K201155 | PleurX Peritoneal Catheter System | PNG | Unknown | |
| K170405 | BD Curve Ascites Shunt | KPM | Unknown | |
| K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle | KNW | Substantially Equivalent | |
| K153748 | AirLife Misty Finity Nebulizer | CAF | Substantially Equivalent | |
| K160437 | PleurX Peritoneal Catheter System | PNG | Unknown | |
| K160450 | Pleurx Pleural Catheter System | DWM | Substantially Equivalent | |
| K151303 | AirLife Infant Heated Wire Circuit | BZE | Substantially Equivalent | |
| K151125 | AVAflex Vertebral Balloon System | HRX | Substantially Equivalent | |
| K150523 | AVAmax Vertebral Balloon | HRX | Substantially Equivalent | |
| K141965 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT | DWM | Substantially Equivalent | |
| K141722 | CAREFUSION GOLD TISSUE MARKER | NEU | Substantially Equivalent | |
| K143234 | MaxZero Administration Sets | FPA | Substantially Equivalent | |
| K141552 | ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS | KNW | Substantially Equivalent | |
| K140831 | MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR | FPA | Substantially Equivalent | |
| K131820 | AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G | HRX | Substantially Equivalent | |
| K131824 | AVAFLEX VERTEBRAL BALLOON SYSTEM | HRX | Substantially Equivalent | |
| K132413 | MZ1000 | FPA | Substantially Equivalent | |
| K123527 | AIRLIFE | CAF | Substantially Equivalent | |
| K122422 | PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER | PNG | Unknown | |
| K121849 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE | DWM | Substantially Equivalent | |
| K120518 | END TIDAL CO2 NASAL CANNULA | CCK | Substantially Equivalent | |
| K113854 | PLEURX PERITONEAL CATHETER SYSTEM | PNG | Unknown | |
| K112831 | PLEURX PLEURAL CATHETER SYSTEMS | DWM | Substantially Equivalent | |
| K103211 | AVEA VENTILATOR | CBK | Substantially Equivalent | |
| K101643 | MODEL LTV 1100 VENTILATOR | CBK | Substantially Equivalent | |
| K103064 | AVAMAX VERTEBRAL BALLOON | NDN | Substantially Equivalent | |
| K093463 | AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 | NDN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- PWHAdministrations Sets With Neuraxial Connectors
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- DWMApparatus, Suction, Patient Care
- HRXArthroscope
- NDNCement, Bone, Vertebroplasty
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- KNWInstrument, Biopsy
- NEUMarker, Radiographic, Implantable
- CAFNebulizer (Direct Patient Interface)
- PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- KPMShunt, Peritoneal
- FMFSyringe, Piston
- CBKVentilator, Continuous, Facility Use
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