BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    SWIFT LT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO VIKING OPTIMA GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MOJAVE CATARACT EXTRACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 29, 2024

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code BTI·April 23, 2013

    ZEPHYR DR

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

    APEX MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·May 2, 2011

    NSK

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

    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

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018