BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    PROSTATE SEEDING NEEDLE

    FDA 510(k)
    FDA Class 1 ·Radiology

    artegral HD

    FDA UDI
    Merz Dental GmbH·D7091973184·posteriors; shade BL3; size M; upper jaw

    BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle

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

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·February 21, 2013

    SYNCHRON LX® I 725 CLINICAL SYSTEM

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

    DURALOC CONST LINER 50X28

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.1818910·Product code JDI·August 1, 2014

    LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 3, 2024

    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

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024