BEUDAMED
    116 results · 38ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.

    FDA Enforcement
    Class I ·Terminated·CareFusion 203, Inc.·July 25, 2012

    CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.

    FDA Enforcement
    Class I ·Terminated·CareFusion 203, Inc.·October 1, 2014

    SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·January 22, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·July 21, 2015

    Alaris System PC Unit Model 8015. modular infusion pump and monitoring system

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    Alaris Pump Module Model 8100

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·August 30, 2013

    Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·May 12, 2016

    Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·March 24, 2016

    Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code CCK·July 1, 2019

    SmartSite Add-On Bag Access Device, Model No. 10013365

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·November 17, 2016

    Alaris Pump Module Model 8100, a modular infusion pump and monitoring system

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·November 8, 2013

    SmartSite Extension Set, Model No. 20029E, intravascular administration set.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·March 19, 2014

    Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800, 688-624200, 688-624300, 842-687900, 672-610800F. Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe.

    FDA Recall
    Terminated ·CareFusion 209 Inc.·Product code GYC·October 5, 2011

    Alaris PC units, Model No. 8015. Infusion pump.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·March 12, 2015

    MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·February 20, 2017

    Alaris PC Unit, Model 8015

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 12, 2017

    Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·August 8, 2016