BEUDAMED
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    ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70608871·2D Lingualbrackets 2. Gen. 400 Brackets w. hook

    DRX HBA1C

    FDA 510(k)
    FDA Class 2 ·Hematology

    INSULIN PEN NEEDLE ADAPTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Injury ·ANGIOMED GMBH & CO.·Product code FGE·November 21, 2008

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO.·Product code FGE·November 5, 2008

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code FGE·February 20, 2009

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO.·Product code FGE·November 4, 2008

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO, MEDIZINTECHNIK·Product code FGE·February 13, 2009

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 26, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·March 14, 2011

    SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Other ·STAAR SURGICAL CO.·Product code HQL·June 13, 2008

    EVOLUT FX VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·July 9, 2025

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 4, 2023

    Contour¿ next GEN Blood Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

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