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

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    Peel-Away Introducer Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Dandy Clear Aligners

    FDA UDI
    Orthly, Inc.·00860006891206·

    AMC

    FDA UDI
    Advantage Medical Electronics, LLC·00849593003681·Subminiature Body Half to BPF QuickConnect Conn...

    PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OTA COLLAGEN BIOMATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 17, 2013

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 23, 2011

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008

    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