BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS

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

    CODMAN BACTISEAL EVD CATHETER SET

    FDA 510(k)
    FDA Class 2 ·Neurology

    XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BACT/ALERT® FA PLUS CULTURE BOTTLE

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code MDB·November 19, 2015

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 6, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 8, 2013

    VITALITY VR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018