BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    RAC 2A MODULE HOUSING

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)

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

    CW DOPPLER/4.5 MHZ

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIGACLIP ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GDO·July 24, 1997

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 19, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 1, 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