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

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    CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE

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

    DSQ Alert® HT Norovirus GII Probe Mix ASR

    FDA UDI
    Elitechgroup Mdx LLC·03661540952876·Product Description DSQ Alert® HT Norovirus GII...

    RETRACTOR ATRIAL RAKE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896070271·HEARTLINE RETRACTOR ATRIAL RAKE

    RETRACTOR ATRIAL RAKE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09928008220·HEARTLINE RETRACTOR ATRIAL RAKE

    ACUMED

    FDA UDI
    Acumed LLC·10806378045066·Distal Radius Fragment Specific Insert

    AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VU APOD INTERVERTABRAL BODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMP RVRS 25MM BSPLT HA+ADPTR

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·May 8, 2014

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FAE·October 17, 2012

    PFC SIGMARP STB TB IN 3 12.5

    FDA Adverse Event
    Injury ·DEPUY (IRELAND)·Product code NJL·August 10, 2010

    FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.

    FDA Recall
    Open, Classified ·Edwards Lifesciences, LLC·Product code MUD·March 1, 2022

    FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

    FDA Recall
    Open, Classified ·Edwards Lifesciences, LLC·Product code MUD·March 1, 2022

    Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code KRA·February 9, 2009

    Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating) REF: 139HF75P For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code KRA·February 9, 2009

    Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (an Antimicrobial *Heparin Coating) For use with Vigilance Monitor. REF: 139HF75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code KRA·February 9, 2009

    Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2 Thermodilution Catheter with AMC THROMBOSHIELD (an Antimicrobial * Heparin Coating) For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 744HF75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code DYG·February 9, 2009

    Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating) For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746HF8 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code DYG·February 9, 2009

    Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746F8 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code DYG·February 9, 2009

    Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73. Product Usage: The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular, ejection, fraction, and end diastolic volume.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code DXG·September 12, 2008

    AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss system; Encompass Therapuetic Support Systems, Glendale, CA. The device is intended to treat or prevent decubitus ulcers, extensive burns, urinary tract blockage and to aid circulation.

    FDA Recall
    Terminated ·Encompass Therapeutic Support Systems dba BG North America·Product code FNM·March 5, 2010