BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    CLEANFLOW SYSTEM

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

    HARMONE-SCHWARZER EEG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    IMESH TACKER

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

    SOLETRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·November 22, 2010

    UNKNOWN RIGHT ABGII HIP STEM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code KWY·January 8, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 2, 2014

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015

    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