BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    ACID FAST BACILLI STAIN CONTROL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VertebraLINK

    FDA UDI
    LINKSPINE, INC.·00817329023739·6mm Kerrison

    VertebraLINK

    FDA UDI
    LINKSPINE, INC.·00817329023722·3mm Kerrison

    VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    uNion® MAX Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    M2A-MAGNUM PF CUP 50ODX44ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 30, 2014

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·November 20, 2012

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code LGD·September 21, 2010

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018