BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    COBAS INTEGRA HDL-CHOLESTEROL DIRECT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AIR-FLOW MASTER STANDARD

    FDA 510(k)
    FDA Class 1 ·Dental

    OPTICROSS HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 28, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 7, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 22, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 11, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·April 3, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·December 11, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 16, 2025

    PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOC

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·September 29, 2023

    OPTICROSS? HD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·January 13, 2026

    PROSIMA PELVIC FLOOR REPAIR KIT

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·February 21, 2013

    CONTOUR CUTTER STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 1, 2014

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·Product code GKZ·January 28, 2011

    OPTICROSS? HD

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 22, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 26, 2025

    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