BEUDAMED
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    HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GEMSTAR SPLT SET Y-EXT W/ BACKCHK 282CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2013

    UNK

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011

    GEMSTAR 1.2 MICRON FLTR 244CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·December 5, 2013

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526159815·PROTECT.LEVA ANKLE SUPPORT GRAY VI

    FITLIFE

    FDA UDI
    Respironics, Inc.·00606959023031·FitLife Mask with Headgear, Large, Japan

    Durable BP Cuff

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935108528·

    ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    KARL STORZ HYSTEROMAT II

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·April 5, 2013

    PENUMBRA SYSTEM ASPIRATION PUMP

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code BTA·March 11, 2011

    PLUM XLMD PUMP

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·June 12, 2008

    BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Manual; Model number: AM134-5MP; Lot Numbers: AM134P1005

    FDA Recall
    Terminated ·Biogenex Laboratories·Product code MVC·February 9, 2006

    Contour¿ next GEN Blood Glucose Monitoring System

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

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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