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

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    PERFUSION TUBING SET

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

    WAVE O SPINAL SYSTEM

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169244634·CAGE 2760922 WAVE O 9MM X 22MM 6DEG

    OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)

    FDA 510(k)
    FDA Class 2 ·Hematology

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·April 9, 2014

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 17, 2007

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 26, 2012

    Heritage Labs Appraise A1c Diabetes Home Test , Product K7609, 24 kits/shipping carton (Product K7609), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions Blood specimen collection

    FDA Recall
    Terminated ·Heritage Labs International LLC·Product code LCP·January 9, 2011

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025