BEUDAMED
    12 results · 17ms · Sources: EU EUDAMED, US FDA

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    CHIN DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    CorticaLINK Spinal Fusion Platform

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432

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

    BD FACSCALIBUR¿ FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 31, 2023

    FEATHERLIGHT TRANSPORT CHAIR

    FDA Adverse Event
    Injury ·SHANGHAI HUBANG MEDICAL APPLIANCES CO LTD.·Product code INN·February 14, 2013

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Malfunction ·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 7, 2011

    FLOTRAC SENSOR

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DRS·August 1, 2014

    BD FACSCALIBUR FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

    BD FACSCALIBUR¿ FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

    BD FACSCALIBUR¿ FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 20, 2023

    BD FACSCALIBUR¿ FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 24, 2023

    Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abuse Panel Plus TCA (K973784), & Triage Drugs of Abuse Panel Plus PPX (K014247) Model Number: 90008, 92002, & 92000 Type of Packaging (i.e. box, plastic bag): For all affected device types: 25 individually pouched devices in a labeled kit box. The Triage Drugs of Abuse Panel plus Tricyclic Antidepressants utilizes a patented immunochemistry, ASCENDTM MULTIMMUNOASSAY (AMIATM). Each AMIATM assay is a competitive binding immunoassay in which a chemically labeled drug (drug conjugate) competes with drug which may be present in the urine for antibody binding sites. After a brief incubation, the reaction mixture is transferred to the membrane in the Detection Area. Free drug conjugate that is displaced from antibody binding sites by drug in the urine, binds to a zone of monoclonal antibody that is immobilized on the membrane. The membrane is washed to remove the unbound conjugate and clear the background. Test results are visually read. The Triage Drugs of Abuse Panel plus Tricyclic Antidepressants is an immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse, (Phencyclidine, Benzodiazepines, Cocaine Metabolite, Amphetamines, THC, Opiates, Barbiturates), and Tricyclic Antidepressants in urine.

    FDA Recall
    Terminated ·Alere San Diego·Product code DIS·January 4, 2012