BEUDAMED
    186 results · 15ms · Sources: EU EUDAMED, US FDA

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    stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation

    FDA Enforcement
    Class II ·Ongoing·Wright Medical Technology, Inc.·May 3, 2023

    stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation

    FDA Enforcement
    Class II ·Ongoing·Wright Medical Technology, Inc.·May 3, 2023

    Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

    FDA Enforcement
    Class II ·Ongoing·Palodex Group Oy·August 21, 2024

    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

    FDA Enforcement
    Class II ·Ongoing·Mizuho OSI·August 31, 2022

    Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

    FDA Enforcement
    Class II ·Ongoing·Mizuho OSI·March 31, 2021

    UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006

    FDA Enforcement
    Class II ·Ongoing·UFSK - International OSYS Gmbh·July 26, 2023

    CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit

    FDA Enforcement
    Class II ·Ongoing·Terumo Cardiovascular Systems Corporation·July 2, 2025

    Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A

    FDA Enforcement
    Class II ·Ongoing·TruAbutment Inc.·March 19, 2025

    Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·April 15, 2026

    Discovery MR750w 3.0T, whole body magnetic resonance scanner

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 4, 2024

    Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·November 18, 2020

    Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·November 18, 2020

    Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·November 18, 2020

    NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176

    FDA Enforcement
    Class II ·Ongoing·Thor Photomedicine Ltd·December 13, 2023

    Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·August 5, 2020

    Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·August 5, 2020

    Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·August 5, 2020

    NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183

    FDA Enforcement
    Class II ·Ongoing·Thor Photomedicine Ltd·December 13, 2023

    NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.

    FDA Enforcement
    Class II ·Ongoing·Thor Photomedicine Ltd·December 13, 2023

    Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

    FDA Enforcement
    Class II ·Ongoing·Terumo Cardiovascular Systems Corporation·April 9, 2025