BEUDAMED
    26 results · 25ms · Sources: EU EUDAMED, US FDA

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    XPERT MRSA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A

    FDA 510(k)
    FDA Unclassified ·Unknown

    AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

    C21617 DE LIFE SYSTEMS $PHISIO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 24, 2013

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 25, 2025

    QUATTRODE LEAD WIDE SPACED, 30 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 8, 2015

    FORMULA

    FDA Adverse Event
    Malfunction ·STRYKER·Product code HRX·April 16, 2013

    LIGACLIP** CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 27, 2011

    SYNCHROMED EL

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code LKK·July 7, 2008

    CP82200 I MIRANDOLA

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·April 6, 2012

    CP85341 FR PARIS

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011

    EMORY/CL/KNNSTN ATLANTA GA1

    FDA Adverse Event
    Other ·SORIN GROUP USA·Product code DWF·August 19, 2010

    DUKE UNIV DURHAM NC 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·July 15, 2011

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA SRL·Product code KFM·November 23, 2016

    COBE CARDIOVASCULAR REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    SORIN GROUP ITALIA·Product code KFM·February 29, 2016

    REVOLUTION CENTRIFUGAL BLOOD PUMP

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code KFM·July 20, 2018

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA SRL·Product code KFM·October 6, 2016

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    SORIN GROUP ITALIA SRL·Product code KFM·October 5, 2016

    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, inoninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operators manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs. K992929: The Dash 3000 Patient Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e. ambulance, etc.) and fixed and rotary winged aircraft, and prehospital emergency response. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, and carbon dioxide as summarized in the operators manual. The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care. This information can be displayed, trended, stored, and printed.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·December 5, 2013