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

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    TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG

    FDA 510(k)
    FDA Class 2 ·Immunology

    IVENT 201 PORTABLE VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SP2 TIBIAL RADEL IMPACTOR

    FDA Adverse Event
    Malfunction ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ? REG.·Product code LXH·June 2, 2014

    VICTORY XL DR

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·November 21, 2012

    DIST TIB MEDIAL RT 9H

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HRS·September 17, 2010

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017