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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MotoBAND CP Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WBR XPRESS PET

    FDA 510(k)
    FDA Class 2 ·Radiology

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 15, 2014

    RESTORE SENSOR

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

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 23, 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