BEUDAMED
    23 results · 22ms · Sources: EU EUDAMED, US FDA

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    IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ALN OPTIONAL VANA CAVA FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK COMFORT CURVE

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·October 1, 2005

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·February 2, 2017

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ILS·May 29, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 19, 2011

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 22, 2008

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·April 4, 2018

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·November 15, 2017

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·November 7, 2017

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·May 15, 2019

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·August 18, 2017

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·April 4, 2018

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·April 5, 2018

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·April 11, 2018

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·April 2, 2018

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·March 30, 2018

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC·Product code LPB·May 10, 2023

    Allura CV20, system code 722031

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020