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

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    NORAPAD PLAIN; NORAPAD TA

    FDA 510(k)
    FDA Class 2 ·Neurology

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033576137·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033576175·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033576151·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033576120·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033576144·

    JOE FRESH

    FDA UDI
    FGX INTERNATIONAL INC.·00193033576168·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0142080·Trial, TLIF, 32L OB CRV 7Deg, 8mm

    BREEZY WHEELCHAIR, MODEL 300

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9

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

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code LRK·February 12, 2013

    VICTORY XL DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011

    GE OEC 9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 12, 2008

    DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·July 3, 2013

    Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor.

    FDA Enforcement
    Class II ·Terminated·Medrad Mr Inc·January 29, 2014

    DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.

    FDA Enforcement
    Class III ·Terminated·DeVilbiss Healthcare LLC·July 9, 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