BEUDAMED
    66 results · 21ms · Sources: EU EUDAMED, US FDA

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    Model No. CYF-5R, Cystonephrofiberscope

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    Model No. CYF-5, Cystonephrofiberscope

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    Model No. BF-XP190, EVIS EXERA III Bronchovideoscope

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    Model No. BF-P190, EVIS EXERA III Bronchovideoscope

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    Model No. CYF-V2, VISERA Cysto-Nephro Videoscope

    FDA Enforcement
    Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

    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

    MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·May 13, 2015

    Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.

    FDA Enforcement
    Class III ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023