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

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    DSL ERYTHROPOIETIN (DSL # 1100)

    FDA 510(k)
    FDA Class 2 ·Hematology

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517963031·Brigade Lateral Trial, 8x38x28mm 8°

    MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SET SCREW, TI GAMMA3® Ø8X17.5MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·July 22, 2014

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 9, 2015

    COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. (AF-IRVINE)·Product code OAD·January 3, 2013

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·November 16, 2010

    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