BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    BED ALERT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228725221·GC Initial™ IQ/Effect Ingot A2-M, 4 pcs. X 5g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556709655·GC Initial™ IQ/Effect Ingot A2-M, 4 pcs. X 5g

    THERMOFORM SHEET MATERIALS AND ACCESSORIES

    FDA 510(k)
    FDA Unclassified ·Unknown

    Mazor X

    FDA 510(k)
    FDA Class 2 ·Neurology

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·May 21, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·October 12, 2010

    MAMMOMARK BIOPSY IDENTIFIER

    FDA Adverse Event
    Malfunction ·DEVICOR MEDICAL PRODUCTS INC.·Product code KNW·December 12, 2012

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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