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

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    LABELLING CHANGES TO IMPRES-MB-X

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377068507·RELINE C Screw, 3.5x8mm MA

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517963192·Brigade Lateral Trial, 6x38x28mm 12°

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065845·EXTRAORAL ELASTICS 3/8" 8 oz

    RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    NC-STAT

    FDA 510(k)
    FDA Class 2 ·Neurology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 30, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 9, 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