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

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    VACCESS PTA BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MYSPINE MC VERTEBRA L04

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·July 6, 2018

    INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TOTAL O2

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    REDUCTION CANNULATED PEDICLE SCREW 5X45

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·February 17, 2023

    MYSPINE S01 DRILL BASED GUIDE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·December 12, 2018

    MYSPINE-MC DRILL GUIDE L03

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PQC·May 26, 2023

    MYSPINE STOPPER SLEEVE 30 MM, DRILL2.7 - LUMBAR

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LXH·February 26, 2020

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 23, 2013

    2017865-2008-02251

    FDA Adverse Event
    Injury ·Product code DTB·July 11, 2008

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·May 1, 2011

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·July 16, 2025

    MYSPINE UNILATERAL LEFT GUIDE S01

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024

    ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·January 10, 2024

    BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 2, 2023

    BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 2, 2023

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2024

    MYSPINE MYSPINE MC DRILL BASED GUIDE L04

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PQC·February 14, 2020

    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

    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 Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 29, 2014