BEUDAMED
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    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

    The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.

    FDA Enforcement
    Class II ·Ongoing·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION·November 13, 2024

    PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023

    CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023

    PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023

    GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023

    GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023

    CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026

    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670

    FDA Enforcement
    Class II ·Completed·Beckman Coulter Mishima K.K.·June 11, 2025

    MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Hitachi Ltd., Medical System Operations Group·May 9, 2018

    SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.

    FDA Enforcement
    Class II ·Ongoing·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION·November 13, 2024

    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·December 24, 2014

    DxC 700 AU, REF: B86444, B86446

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026

    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·August 7, 2024

    Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR

    FDA Enforcement
    Class II ·Ongoing·Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha·March 4, 2026

    Shimadzu, Trinias, Digital Angiography System

    FDA Enforcement
    Class II ·Ongoing·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION·March 20, 2024

    Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

    FDA Enforcement
    Class II ·Ongoing·Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha·March 4, 2026

    PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021