BEUDAMED
    223 results · 17ms · Sources: EU EUDAMED, US FDA

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    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

    ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

    FDA Enforcement
    Class II ·Ongoing·Orthorebirth Co Ltd·May 13, 2026

    BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC

    FDA Enforcement
    Class II ·Ongoing·Orthorebirth Co Ltd·May 13, 2026

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

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

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

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

    DxC 700 AU, REF: B86444, B86446

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

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

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

    Olympus OER-Elite

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 10, 2025

    Olympus OER-Pro

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 10, 2025

    Olympus OER-Mini

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 10, 2025

    Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL

    FDA Enforcement
    Class II ·Ongoing·Shimadzu Corp. Analytical & Measuring Instruments Div.·December 4, 2024

    Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

    FDA Enforcement
    Class II ·Ongoing·Shimadzu Corp. Analytical & Measuring Instruments Div.·December 4, 2024

    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

    Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.

    FDA Enforcement
    Class II ·Ongoing·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION·October 30, 2024

    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

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    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

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024