BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    POTASSIUM DILUENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MONDEAL

    FDA UDI
    MONDEAL Medical Systems GmbH·04050435062520·MCD Screw 3.0 x 36 mm M2 non lo...

    C-PORT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TELERADPRO EDGE; TELERADPRO EDGE HD-CCD

    FDA 510(k)
    FDA Class 2 ·Radiology

    GYNECARE TVT OBTURATOR

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·October 31, 2019

    SYS 6 STERILIZATION CASE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·May 23, 2014

    PENUMBRA ASPIRATION PUMP

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code BTA·March 15, 2010

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 13, 2012

    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