BEUDAMED
    10 results · 31ms · Sources: EU EUDAMED, US FDA

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    ALLKARE(TM) ADHESIVE REMOVER WIPE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    HERCULITE XRV

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EBF·November 26, 2014

    OPTI-PLAST 5F PTA CATHETERS, MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CINE'VIEW - STRESS ECHO & IMAGE REVIEW

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HERCULITE XRV

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EBF·November 26, 2014

    HERCULITE XRV

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EBF·November 26, 2014

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·January 17, 2013

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·November 22, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 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