BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    BILICHEK NON-INVASIVE BILIRUBIN ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091983071·posteriors; shade B4; size S; lower jaw

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018

    VLIFT-s Vertebral Body Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERTEX RECONSTRUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 22, 2019

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 14, 2018

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 5, 2018

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Injury ·HEARTWARE, INC·Product code DSQ·February 28, 2013

    ITREL 3

    FDA Adverse Event
    Injury ·MEDTRONIC EUROPE SARL·Product code LGW·February 4, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·August 6, 2014

    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