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

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    PLATEAU SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DRIVER; SIZE 10

    FDA Adverse Event
    Malfunction ·K2M, INC.·Product code LXH·July 12, 2022

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741118350·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674111835060·

    Flexitron

    FDA UDI
    Nucletron B.V.·08717213026810·Flexitron Transfer Tube for Metal Needles (28)

    MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079

    FDA 510(k)
    FDA Class 2 ·Neurology

    COBE REVOLUTION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·March 8, 2019

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 14, 2013

    VITROS 5600 INTEGRATED SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·June 2, 2011

    SILICONE ULTRAVIOLET - ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOC

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL·Product code HQL·August 13, 2008

    TRI-STAPLE 2.0

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·February 13, 2024

    LIBRE 2 SENSOR FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code QLG·February 9, 2024

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·November 21, 2022

    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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021