BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMAGINE H.E. PRESS DESIGN-CERAMIC

    FDA 510(k)
    FDA Class 2 ·Dental

    AVL HINGE KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    5.0 CM SHORT ATTACHMENT

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 5, 2013

    STERRAD NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 12, 2008

    RESERVOIR 1.8 ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 8, 2011

    FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

    FDA Adverse Event
    Death ·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023

    FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

    FDA Adverse Event
    Death ·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·January 29, 2021

    Contour¿ next GEN Blood Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023