BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WOODLYN CLASSIC KERATOMETER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HAEMOFUGE A. BIOFUGE A. & B

    FDA 510(k)
    FDA Class 2 ·Hematology

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE-NORTH AMERICA·Product code KDI·May 16, 2008

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 1, 2012

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 12, 2014

    SETROX S 53

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·September 21, 2010

    Extremity Pack-N Brunswick, part number PSS1866(A

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018