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

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    LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207

    FDA 510(k)
    FDA Class 2 ·Immunology

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984476·anteriors; shade C2; mould R 86

    CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VESSEL DILATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·February 1, 2011

    SELOX ST 53

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·August 6, 2014

    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