BEUDAMED
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    INTRAVENOUS ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ERA® Implant Abutment Standard 0°, 3mm Cuff (BF)

    FDA UDI
    STERNGOLD DENTAL LLC·00841549103124·Implant retained overdentures are an establishe...

    LCCS INSULATED SPINAL NEEDLE (RF CANNULA)

    FDA 510(k)
    FDA Class 2 ·Neurology

    AVANTE MICRO CRYSTAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    CONSERVE(R) PLUS CUP

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code KWA·May 15, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 31, 2012

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 2, 2015

    URETERAL BRUSH BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FDX·November 15, 2023

    URETERAL BRUSH BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FDX·January 7, 2022

    Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·February 25, 2015

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

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