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

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    MRI STRETCHER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BOUNDARY SINGLE-USE GOWNS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CREATININE REAGENT FOR DEMAND ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 18, 2014

    CELL-DYN EMERALD DILUENT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·October 19, 2010

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION·Product code FRN·December 14, 2012

    SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    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