ClearanceBrief
Company · US

Care Fusion

FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2024. Name variants (Inc, Corp, punctuation) are merged.

34510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
FPASet, Administration, Intravascular6
DWMApparatus, Suction, Patient Care4
HRXArthroscope4
PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling4
CAFNebulizer (Direct Patient Interface)2
CBKVentilator, Continuous, Facility Use2
KNWInstrument, Biopsy2
NDNCement, Bone, Vertebroplasty2
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer1
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1
FMFSyringe, Piston1
KPMShunt, Peritoneal1
LHISet, I.V. Fluid Transfer1
NEUMarker, Radiographic, Implantable1
ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System1
PWHAdministrations Sets With Neuraxial Connectors1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Mar 6, 2024K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device
Care Fusion
LHI
Sep 25, 2023K231888BD Texium™ Needle-Free Syringe
Care Fusion
FMF
Jul 21, 2023K221327BD Alaris™ Pump Infusion Sets
Care Fusion
FPA
Jul 21, 2023K221319BD Alaris™ Pump Epidural Infusion Set
Care Fusion
PWH
May 12, 2023K223101BD Secondary Infusion Set
Care Fusion
FPA
Apr 7, 2023K223088BD SmartSite™ Needle-Free Connector
Care Fusion
FPA
Mar 24, 2023K223076BD Texium™ Closed Male Luer
Care Fusion
ONB
Oct 21, 2020K201155PleurX Peritoneal Catheter System
Care Fusion
PNG
Nov 2, 2017K170405BD Curve Ascites Shunt
Care Fusion
KPM
Sep 11, 2017K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve B
Care Fusion
KNW
May 17, 2017K153748AirLife Misty Finity Nebulizer
Care Fusion
CAF
Nov 3, 2016K160437PleurX Peritoneal Catheter System
Care Fusion
PNG
Oct 31, 2016K160450Pleurx Pleural Catheter System
Care Fusion
DWM
Jan 21, 2016K151303AirLife Infant Heated Wire Circuit
Care Fusion
BZE
Nov 24, 2015K151125AVAflex Vertebral Balloon System
Care Fusion
HRX
Oct 29, 2015K150523AVAmax Vertebral Balloon
Care Fusion
HRX
Jul 2, 2015K141965PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
Care Fusion
DWM
Jan 23, 2015K141722CAREFUSION GOLD TISSUE MARKER
Care Fusion
NEU
Nov 20, 2014K143234MaxZero Administration Sets
Care Fusion
FPA
Sep 5, 2014K141552ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
Care Fusion
KNW
Apr 15, 2014K140831MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
Care Fusion
FPA
Oct 4, 2013K131820AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G
Care Fusion
HRX
Oct 3, 2013K131824AVAFLEX VERTEBRAL BALLOON SYSTEM
Care Fusion
HRX
Aug 29, 2013K132413MZ1000
Care Fusion
FPA
Apr 25, 2013K123527AIRLIFE
Care Fusion
CAF
Oct 24, 2012K122422PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
Care Fusion
PNG
Oct 18, 2012K121849PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE
Care Fusion
DWM
May 4, 2012K120518END TIDAL CO2 NASAL CANNULA
Care Fusion
CCK
Mar 19, 2012K113854PLEURX PERITONEAL CATHETER SYSTEM
Care Fusion
PNG
Feb 16, 2012K112831PLEURX PLEURAL CATHETER SYSTEMS
Care Fusion
DWM
May 12, 2011K103211AVEA VENTILATOR
Care Fusion
CBK
Jan 26, 2011K101643MODEL LTV 1100 VENTILATOR
Care Fusion
CBK
Jan 10, 2011K103064AVAMAX VERTEBRAL BALLOON
Care Fusion
NDN
Feb 26, 2010K093463AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
Care Fusion
NDN

Latest recalls

DateFirm and productCodeLinked 510(k)
No recalls in this window.
Get alerts for these product codes