BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ActivOrtho Continuous Compression Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MIO MEDIUM (MOTILITY INDOLE ORNITHINE)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TITANIUM SCREW LOW PROFILE 5X40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016

    TITANIUM SCREW LOW PROFILE 5X40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·March 6, 2013

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·February 15, 2011

    VIRTUOSO

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·August 8, 2014

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016