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

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    Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLEARSTAR PUMP

    FDA Adverse Event
    Malfunction ·ABBOTT NUTRITION·Product code LZH·October 15, 2008

    CAPSURE SP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·July 2, 2013

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021