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

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    R&D BATTERIES, INC. PART NUMBERS 5039, 5052, 5056 AND 5061

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU

    FDA 510(k)
    FDA Class 2 ·Hematology

    core nova Complete Operating Room Endoscopy

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 8, 2013

    MIS DISTAL RESECTION GUIDE RT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·December 14, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 22, 2014

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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