BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    ENDOBRUSH

    FDA 510(k)
    FDA Class 1 ·Dental

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556702625·GC Initial™ MC Powder Opaque OB2, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228701771·GC Initial™ MC Powder Opaque OB2, 20g

    FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES

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

    Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 12, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·December 12, 2012

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 25, 2015

    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