BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    ELI URINE CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFCTURING·Product code DXY·February 9, 2013

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 2, 2014

    SYNCHRON CX/LX CREATININE KINASE (CK) KIT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CKA·January 7, 2011

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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