BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    SAF-GEL HYDRATING DERMAL WOUND DRESSING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STAT K IN VITRO DIAGNOSTIC TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 4, 2013

    REPAIR CORE SAG SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·December 22, 2010

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 17, 2014

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·September 8, 2025

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020