BEUDAMED
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    KODAK MIN-R FAST SCREEN SO-459

    FDA 510(k)
    FDA Class 1 ·Radiology

    Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ABX MINOTROL 16

    FDA Adverse Event
    Other ·HORIBA MEDICAL·Product code GKZ·June 6, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAM·December 6, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 22, 2015

    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code MHX·October 24, 2025

    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code DQA·October 24, 2025

    Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code MHX·October 24, 2025

    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code MWI·October 24, 2025

    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code MHX·October 24, 2025

    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code DQA·October 24, 2025

    Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code MHX·October 24, 2025

    Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code HGM·October 24, 2025

    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code DQA·October 24, 2025

    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code DQA·October 24, 2025

    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code MHX·October 24, 2025

    Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code HGM·October 24, 2025

    Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code HGM·October 24, 2025