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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Country: Japan ×

    HHT-LLD SCM retrofit kit

    Device
    EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·On the market

    HHT-LLD SCM retrofit kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·1 device

    Goodman Co. Ltd.

    Manufacturer
    🇯🇵 Japan·1 Basic UDI-DI·1 Device

    Saraya Co., Ltd.

    Manufacturer
    🇯🇵 Japan

    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 Enforcement
    Class II ·Completed·Fukuda Denshi Co., Ltd.·December 13, 2017

    Ohira Co.,Ltd.

    Manufacturer
    🇯🇵 Japan·3 Basic UDI-DIs·7 Devices·15 Importers·SGS Belgium NV

    Rexxam Co.,Ltd

    Manufacturer
    🇯🇵 Japan·3 Basic UDI-DIs·6 Devices·18 Importers

    TOWA MEDICAL INSTRUMENTS CO.,LTD.

    Manufacturer
    🇯🇵 Japan·4 Basic UDI-DIs·4 Devices·15 Importers·SGS FIMKO OY

    FINDEX Inc.

    Manufacturer
    🇯🇵 Japan·1 Basic UDI-DI·1 Device·8 Importers

    Goodman Co., Ltd. Goodman Research Center

    Manufacturer
    🇯🇵 Japan

    HAEMOSTASIS VALVES

    Device
    EU MDR · Eu Md Class 2a ·Goodman Co. Ltd.·On the market·8 countries

    Slit Lamp SL-203

    Device
    EU MDR · Eu Md Class 1 ·Ohira Co.,Ltd.·On the market·32 countries

    Eye-Tracking Perimeter FIELDNavigator

    Device
    EU MDR · Eu Md Class 1 ·FINDEX Inc.·On the market·30 countries

    CP-500

    Device
    EU MDD · Eu Md Class 1 ·TOWA MEDICAL INSTRUMENTS CO.,LTD.·On the market

    BR-7

    Device
    EU MDD · Eu Md Class 1 ·TOWA MEDICAL INSTRUMENTS CO.,LTD.·On the market

    TF-3

    Device
    EU MDD · Eu Md Class 1 ·TOWA MEDICAL INSTRUMENTS CO.,LTD.·On the market·19 countries

    PD-82II

    Device
    EU MDD · Eu Md Class 1 ·TOWA MEDICAL INSTRUMENTS CO.,LTD.·On the market·3 countries

    Applanation Tonometer SL-TM

    Device
    EU MDR · Eu Md Class 1 ·Ohira Co.,Ltd.·On the market·32 countries

    Applanation Tonometer SL-TM

    Device
    EU MDR · Eu Md Class 1 ·Ohira Co.,Ltd.·On the market·32 countries

    Applanation Tonometer SL-TM

    Device
    EU MDR · Eu Md Class 1 ·Ohira Co.,Ltd.·On the market·32 countries