BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    ROOT CANAL POST

    FDA 510(k)
    FDA Class 1 ·Dental

    MW5060195

    FDA Adverse Event
    Death ·February 12, 2016

    ANEROID BLOOD PRESSURE GAUGE

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    DXS DIGITAL X-RAY SUBTRACTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    M / L TAPER KINECTIV MODULAR FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 13, 2018

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 22, 2013

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·December 14, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·July 9, 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