BEUDAMED
    8 results · 29ms · Sources: EU EUDAMED, US FDA

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    SPIDERFX EMBOLIC PROTECTION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LUNG NODULE ASSESSMENT AND COMPARISON OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    UROVYSION BLADDER CANCER RECURRENCE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·November 14, 2019

    PINNACLE 100 ACET CUP 56MM

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 17, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·April 15, 2011

    WALLSTENT BILIARY STENT W/UNISTEP PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·June 18, 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