BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    ASPIRATING ENDO OCULAR PROBE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471144330·PASSING PIN - DRILL TIP 2.4mm DIA x 385mm

    FREE PROTEIN S REAGENT CAT. NO. 5363

    FDA 510(k)
    FDA Class 2 ·Hematology

    TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 14, 2013

    ACCESS 2I (LXI) IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·December 3, 2010

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·July 3, 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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023