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

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    SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA

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

    MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIS ENGINE

    FDA 510(k)
    FDA Class 2 ·Neurology

    BRASSELER

    FDA Adverse Event
    Malfunction ·BRASSELER USA MEDICAL LOGISTICS & MANUFACTURING FACILITY·Product code HWE·April 5, 2013

    INSIGNIA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 13, 2011

    CENTURY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·May 27, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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