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

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    Lumilisse IPL Hair Remover

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EASYSUITE SURGICAL LIGHT CONTROL (ESLC)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ORACLE SPACER, OPAL SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 4, 2022

    BD POSIFLUSH¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·November 12, 2022

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 15, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 31, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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