BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EBCHEK BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 3, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·August 24, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    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