BEUDAMED
    11 results · 30ms · Sources: EU EUDAMED, US FDA

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    FIXATION TROCARS

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

    MODIFICATION TO VIKING OPTIMA GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MOJAVE CATARACT EXTRACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 9, 2018

    LTV 1200 VENTILATOR

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL, INC·Product code CBK·November 13, 2023

    QUICKSITE LV

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. CRMD·Product code OJX·January 10, 2014

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·May 10, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 29, 2008

    LTV 1200 VENTILATOR

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL, INC·Product code CBK·December 13, 2023

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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