BEUDAMED
    57 results · 23ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Status: Terminated × Clear all

    Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    Left Heart Kit, Model Number M20268. for blood pressure monitoring.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·December 5, 2018

    Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

    FDA Enforcement
    Class I ·Terminated·TERRIFIC CARE LLC·February 13, 2019

    Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1333MR. Stopcocks and manifolds are used to control the direction of IV fluid flow. component of extravascular blood-pressure Transducer.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021

    smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 20, 2021

    smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 20, 2021

    smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 20, 2021

    smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 20, 2021

    smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 20, 2021

    smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 20, 2021