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

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    External Counterpulsation System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEUROLINK IP MODEL: PK1117

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYNGO RT THERAPIST CONNECT

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROGRAMMING WAND

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 6, 2008

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 24, 2013

    POSEY STAYSAFE BED

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code FNL·July 29, 2011

    BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 8, 2018

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023

    BD MAX¿ CPO

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025

    BD MAX¿ CPO

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025

    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