BEUDAMED
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    NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    NIAGARA SLIM-CATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    POWER LOAD

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 22, 2013

    REDDICK

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code GBZ·June 26, 2008

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 14, 2011

    MENTOR MEMORYSHAPE BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·September 23, 2025

    MENTOR MEMORYSHAPE BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·September 23, 2025

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·October 21, 2024

    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