BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE

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

    MENTOR CPX 2 BREAST TISSUE EXPANDER

    FDA Adverse Event
    Malfunction ·MENTOR WORLDWIDE LLC·Product code LCJ·August 22, 2017

    CANCELLOUS SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SUPERSTAND 3000

    FDA 510(k)
    FDA Class 1 ·Radiology

    ULTRASITE VALVE NEEDLELESS SYSTEM

    FDA Adverse Event
    Malfunction ·B. BRAUN DOMINICAN REPUBLIC·Product code KGZ·June 6, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·February 21, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·January 28, 2011

    SOLITAIRE FR2

    FDA Adverse Event
    Death ·IRVINE·Product code NRY·February 4, 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