Medical Device Manufacturer · US , Waukegan , IL

Care Fusion

34 submissions · 29 cleared · Since 2010
34
Total
29
Cleared
0
Denied

Care Fusion — FDA 510(k) Submissions

Care Fusion has submitted 34 FDA 510(k) premarket notifications since 2010, of which 29 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Set, Administration, Intravascular, Arthroscope, Apparatus, Suction, Patient Care, Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling, Nebulizer (direct Patient Interface) . Use the specialty filter in the sidebar to narrow results.

34 devices
1–25 of 34
BD SmartSite? 13mm Vial Access Device; BD SmartSite? 20mm Vial Access Device
K233021 · LHI Set, I.v. Fluid Transfer · General Hospital
Mar 2024 166d
BD Texium? Needle-Free Syringe
K231888 · FMF Syringe, Piston · General Hospital
Sep 2023 90d
BD Alaris? Pump Epidural Infusion Set
K221319 · PWH Administrations Sets With... · General Hospital
Jul 2023 441d
BD Alaris? Pump Infusion Sets
K221327 · FPA Set, Administration,... · General Hospital
Jul 2023 441d
BD Secondary Infusion Set
K223101 · FPA Set, Administration,... · General Hospital
May 2023 224d
BD SmartSite? Needle-Free Connector
K223088 · FPA Set, Administration,... · General Hospital
Apr 2023 189d
BD Texium? Closed Male Luer
K223076 · ONB Closed Antineoplastic And... · General Hospital
Mar 2023 175d
PleurX Peritoneal Catheter System
K201155 · PNG Peritoneal, Drainage... · Gastroenterology & Urology
Oct 2020 174d
BD Curve Ascites Shunt
K170405 · KPM Shunt, Peritoneal · Gastroenterology & Urology
Nov 2017 265d
Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
K171531 · KNW Instrument, Biopsy · Gastroenterology & Urology
Sep 2017 109d
AirLife Misty Finity Nebulizer
K153748 · CAF Nebulizer (direct Patient... · Anesthesiology
May 2017 505d
PleurX Peritoneal Catheter System
K160437 · PNG Peritoneal, Drainage... · Gastroenterology & Urology
Nov 2016 260d
Pleurx Pleural Catheter System
K160450 · DWM Apparatus, Suction,... · Anesthesiology
Oct 2016 256d
AirLife Infant Heated Wire Circuit
K151303 · BZE Heater, Breathing System... · Anesthesiology
Jan 2016 248d
AVAflex Vertebral Balloon System
K151125 · HRX Arthroscope · Orthopedic
Nov 2015 210d
AVAmax Vertebral Balloon
K150523 · HRX Arthroscope · Orthopedic
Oct 2015 241d
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
K141965 · DWM Apparatus, Suction,... · Anesthesiology
Jul 2015 346d
CAREFUSION GOLD TISSUE MARKER
K141722 · NEU Marker, Radiographic,... · General & Plastic Surgery
Jan 2015 212d
MaxZero Administration Sets
K143234 · FPA Set, Administration,... · General Hospital
Nov 2014 10d
ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
K141552 · KNW Instrument, Biopsy · Gastroenterology & Urology
Sep 2014 86d
MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
K140831 · FPA Set, Administration,... · General Hospital
Apr 2014 13d
AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G
K131820 · HRX Arthroscope · Orthopedic
Oct 2013 106d
AVAFLEX VERTEBRAL BALLOON SYSTEM
K131824 · HRX Arthroscope · Orthopedic
Oct 2013 105d
MZ1000
K132413 · FPA Set, Administration,... · General Hospital
Aug 2013 27d
AIRLIFE
K123527 · CAF Nebulizer (direct Patient... · Anesthesiology
Apr 2013 160d
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