BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device

    FDA 510(k)
    FDA Class 2 ·Neurology

    NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Siemens 3.0T PROCURE Array Coil

    FDA 510(k)
    FDA Class 2 ·Radiology

    TARGETING ARM PROX. LAT TIBIA LEFT

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012

    COULTER® ACT 5DIFF AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 10, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 11, 2014

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·July 23, 2013

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025