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    FUKUDA DENSHI USA, INC.

    FDA registration
    FUKUDA DENSHI USA, INC.·18 products·🇺🇸 United States

    Fukuda Vital Signs Monitor

    FDA UDI
    FUKUDA DENSHI USA, INC.·00860002604404·Fukuda Denshi USA, Inc. Spot check Vital Signs ...

    Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients.

    FDA Recall
    Terminated ·Fukuda Denshi USA, Inc.·Product code MHX·December 21, 2015

    Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

    FDA Recall
    Completed ·Fukuda Denshi Co., Ltd. 2-35-8 Hongo, Bunkyo-Ku Tokyo Japan·Product code MHX·October 16, 2017

    FUKUDA DENSHI

    FDA Adverse Event
    Death ·FUKUDA DENSHI USA, INC.·Product code DSI·October 22, 2008

    FUKUDA DENSHI

    FDA Adverse Event
    Injury ·FUKUDA DENSHI USA INC.·Product code DRT·June 4, 2009

    FUKUDA DENSHI

    FDA Adverse Event
    Death ·FUKUDA DENSHI USA, INC.·Product code DSI·November 10, 2010

    DENSHI DIAGNOSTIC ULTRASOUND FF-SONIC UF-4500

    FDA Adverse Event
    Malfunction ·FUKUDA DENSHI USA, INC.·Product code IYO·June 18, 1997

    Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients.

    FDA Enforcement
    Class II ·Terminated·Fukuda Denshi USA, Inc.·January 27, 2016

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices