BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    Cascadion™ SM Mixing Tip

    Device
    EU IVDR · Eu Ivd Class A ·Thermo Fisher Scientific Oy·No longer on the market·14 countries

    Cascadion™ SM Mixing Tip

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Thermo Fisher Scientific Oy·1 device

    Vital Signs™ Leadwire Set, Diagnostic Cardiology Universal-ended, Mixed 10/set IEC

    Device
    EU MDR · Eu Md Class 1 ·AirLife Finland Oy·On the market·32 countries

    Vital Signs™ Leadwire Set, Diagnostic Cardiology Universal-ended, Mixed 14/set IEC

    Device
    EU MDR · Eu Md Class 1 ·AirLife Finland Oy·On the market·32 countries

    Vital Signs™ Leadwire Set, Diagnostic Cardiology Universal-ended, Mixed 10/set AHA

    Device
    EU MDR · Eu Md Class 1 ·AirLife Finland Oy·On the market·1 country

    Vital Signs™ Leadwire Set, Diagnostic Cardiology Universal-ended, Mixed 14/set AHA

    Device
    EU MDR · Eu Md Class 1 ·AirLife Finland Oy·On the market·1 country

    GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B450 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation, -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), and spirometry) -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·October 17, 2018

    GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation). -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange) and -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission. The CARESCAPE Monitor B850 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·October 17, 2018

    Kir-Fix Oy

    Importer
    🇫🇮 Finland

    ProMedical Oy

    Importer
    🇫🇮 Finland·5 Manufacturers

    Vital Signs™ Fixed Catheter Mounts

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·AirLife Finland Oy·1 device

    Vital Signs™ Fixed Catheter Mounts

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·AirLife Finland Oy·1 device

    Vital Signs™ Fixed Catheter Mounts

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·AirLife Finland Oy·1 device

    Vital Signs™ Fixed Catheter Mounts

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·AirLife Finland Oy·1 device

    Vital Signs™ Fixed Catheter Mounts

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·AirLife Finland Oy·1 device

    Vital Signs™ Fixed Catheter Mounts

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·AirLife Finland Oy·1 device

    Vital Signs™ Fixed Catheter Mounts

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·AirLife Finland Oy·1 device

    Vital Signs™ Fixed Catheter Mounts

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·AirLife Finland Oy·1 device