BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    HS70A Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·January 10, 2008

    TSRH SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 6, 2007

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 6, 2007

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 7, 2007

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 7, 2007

    UNKNOWN

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 6, 2007

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 7, 2007

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 6, 2007

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·October 24, 2014

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·March 24, 2016

    115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products Inc·June 11, 2014

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014