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

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    REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001

    FDA 510(k)
    FDA Class 2 ·Immunology

    COLLATEK POWDER

    FDA 510(k)
    FDA Unclassified ·Unknown

    VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001

    FDA 510(k)
    FDA Class 2 ·Neurology

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·March 27, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·February 24, 2011

    PCA II PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·April 3, 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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024