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

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    UROMETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MODIFICATION TO HL168

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PLUM XLM W/DATAPORT

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 25, 2014

    PORTEX SPINAL ANESTHESIA TRAY

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code CAZ·November 5, 2012

    PROTEGE RX SELF EXPANDING NITINOL STENT

    FDA Adverse Event
    Injury ·EV3 INC.·Product code NIM·August 25, 2010

    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