BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    CROSSCHECK PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IO-FLEX CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ONE DIMENSIONAL WATER PHANTOM, WP 1D

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2024

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DYB·April 13, 2015

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013

    MOD CON DIST STEM 17 X 155 MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code LZO·June 10, 2011

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code EZW·August 22, 2008

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·July 12, 2016

    Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·December 28, 2016