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

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    CHEMO-SPIKE II RECONSTITUTION DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ABSORBENT FIBER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    HEALTLH ESSENTIALS PERSONAL MASSAGER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GDO·July 31, 1997

    OFFSET DOUBLE CLAMP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SURGICAL·Product code ILZ·August 5, 2015

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 22, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011

    SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024