BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    PARA-PAK (C&S)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SKIN BARRIER FILM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 6, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 16, 2012

    PROLITE ULTRA MESH

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORP.·Product code FTL·May 21, 2015

    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