BEUDAMED
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    TRANSPORT CULTURE MEDIUM DEVICE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    5560 7L SYRINGE

    FDA UDI
    HANS RUDOLPH, INC.·00817136020969·5560 DLco SIMULATOR W/ROLL STD

    ProLift Lateral

    FDA UDI
    Life Spine, Inc.·00190837037499·

    NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TINA-QUANT APOLIPOPROTEIN VER.2

    FDA 510(k)
    FDA Class 2 ·Immunology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2013

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 2, 2014

    DREAMTOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·June 3, 2011

    ITREL 4

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·December 28, 2018

    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·October 10, 2018

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025