BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503

    FDA Enforcement
    Class II ·Ongoing·Masimo Corporation·June 28, 2023

    Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794

    FDA Enforcement
    Class II ·Ongoing·Masimo Corporation·June 28, 2023

    Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

    FDA Enforcement
    Class II ·Terminated·Masimo Corporation·May 8, 2013

    Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895

    FDA Enforcement
    Class II ·Ongoing·Masimo Corporation·June 28, 2023

    Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053

    FDA Enforcement
    Class II ·Ongoing·Masimo Corporation·June 28, 2023

    rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate.

    FDA Enforcement
    Class II ·Terminated·Masimo Corporation·December 2, 2015

    Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.

    FDA Enforcement
    Class II ·Terminated·Masimo Corporation·November 19, 2014

    Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,

    FDA Enforcement
    Class II ·Ongoing·Masimo Corporation·April 24, 2024

    Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,

    FDA Enforcement
    Class II ·Ongoing·Masimo Corporation·April 24, 2024

    Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,

    FDA Enforcement
    Class II ·Ongoing·Masimo Corporation·April 24, 2024

    Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,

    FDA Enforcement
    Class II ·Ongoing·Masimo Corporation·April 24, 2024