BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704261622·

    SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BIS ENGINE

    FDA 510(k)
    FDA Class 2 ·Neurology

    COULTER® LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·April 2, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·March 21, 2011

    TAG

    FDA Adverse Event
    Death ·WL GORE & ASSOCIATES, INC·Product code MIH·April 18, 2008

    BIOSYNC EVANS WEDGE, 18 X 18 X 6.5 MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code PLF·December 7, 2020

    LIFEWISE BLOOD PRESSURE MONITOR

    FDA Adverse Event
    Injury ·RADIOSHACK·Product code DXN·October 20, 2004

    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

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016