BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EVOLUTION NitrX Medial-Pivot Knee

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CEC·April 23, 2012

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023

    BD MULTI-CHECK¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 5, 2023

    BD MULTI-CHECK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023

    BD MULTI-CHECK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023

    AFFINITY THREE BIRTHING BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code HDD·January 25, 2013

    5.5MM TI CANCELLOUS LOCKING SCREW

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code HRS·January 26, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014

    BD MULTI-CHECK¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 26, 2023

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023

    Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·September 23, 2020