BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    PleuraFlow System with FlowGlide

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996133272·LATERAL,COBB DISSECTOR,STRAIGHT SHAFT

    UNISIGHT SYSTEM WITH UNIGATE

    FDA 510(k)
    FDA Class 2 ·Radiology

    APPALEAD GW+03XXXXXXR SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSE GEN MODEL 101

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 15, 2008

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DQX·August 11, 2011

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 2, 2013

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 22, 2023

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    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