BEUDAMED
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    UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125525·PowerChem Neoprene Exam Gloves, Small

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293456·

    Key Surgical K-Wires and Steinmann Pins

    FDA UDI
    KEY SURGICAL, INC.·00849771013020·Steinmann Pins, Double trocar, 9/64-inch (3.5mm...

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049613·Steinmann Pins, Double trocar, 9/64-inch (3.5mm...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704912428·

    Steinmann pin w. double end trocarpoint 3.5mm/229mm, 6 pcs./unit

    FDA UDI
    mahe medical gmbh·EMAHKM714620·Steinmann pin w. double end trocarpoint 3.5mm/...

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659484849·Steinmann pin w. double end trocarpoint _x000D_...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111132001·F.O. MILLER ENG STYLE SZ00 3MM

    Australis ALIF Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215127718·

    CARESIDE HEMOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    OIL FOR TISSUE CULTURE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OCTRODE

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

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 24, 2020

    QUATTRODE LEAD WIDE SPACED, 30 CM

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

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CRMD·Product code NVN·January 14, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·April 22, 2013

    DEPUY ASR XL FEM IMP SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 13, 2011

    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