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

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    SCANSCOPE XT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    ABX PENTRA 60C+ HEMATOLOGY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE·Product code KDJ·April 23, 2013

    ZEPHYR DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·September 9, 2014

    MICRUS MICROCOIL SYSTEM

    FDA Adverse Event
    Malfunction ·MICRUS ENDOVASCULAR CORPORATION·Product code HCG·April 13, 2011

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code DZI·October 6, 2020

    FUSION QUATTRO EXTRACTION BALLOON

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code GCA·May 20, 2022

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code DZI·July 15, 2025

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code ELC·September 9, 2016

    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