BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    NON REBREATHING VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613023560·Kelly Scissors, Curved, Overall Length 7" (180mm)

    UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PENUMBRA SYSTEM MAX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    11CM ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·January 8, 2013

    NC QUANTUM APEX PTCA DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·December 2, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 14, 2014

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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 Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015