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

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    DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SYNCHRON (R) SYSTEMS CREATININE REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CGX·July 2, 2011

    BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KING SIZE HEAT PAD

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 6, 2013

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 3, 2011

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·July 18, 2014

    PKG, PKG, HOOK SCISSORS, P/N 0250080260. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014