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

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    V8 TRANSLUMINAL BAV CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARSTASIS ACCESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEPAIRX VENTILATING AIR PURIFIER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Other ·ARSTASIS INC.·Product code DYB·November 15, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Malfunction ·ARSTASIS, INC.·Product code DYB·November 19, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Other ·ARSTASIS, INC.·Product code DYB·November 22, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Injury ·ARSTASIS, INC.·Product code DYB·November 1, 2010

    CD HORIZON BALLAST SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019

    ITREL 3

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·May 29, 2013

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·June 17, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 21, 2008

    MYSPINE STANDARD DRILL GUIDE T07

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code MNI·May 10, 2019

    Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX

    FDA Enforcement
    Class II ·Terminated·Neurotherm, Inc.·April 20, 2016

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023