BEUDAMED
    146 results · 14ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    LITe Decompression Snake Arm, REF 48080230

    FDA Enforcement
    Class II ·Ongoing·Stryker Spine·December 27, 2023

    Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·March 22, 2023

    Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.

    FDA Enforcement
    Class II ·Ongoing·Medagent Inc·March 6, 2024

    Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.

    FDA Enforcement
    Class II ·Ongoing·Shimadzu Medical Systems·December 16, 2020

    ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Ongoing·Shimadzu Medical Systems·December 16, 2020

    MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Ongoing·Shimadzu Medical Systems·December 16, 2020

    Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·May 13, 2026

    Cirq Arm System 2.0

    FDA Enforcement
    Class II ·Ongoing·Brainlab AG·April 5, 2023

    Integra Universal Flexible Arm part number REF 1362275

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·April 20, 2022

    LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Support Arm Model Numbers

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·October 11, 2023

    OPMI LUMERA 300, REF 6137

    FDA Enforcement
    Class II ·Ongoing·Carl Zeiss Suzhou Co., Ltd.·November 1, 2023

    SOZO Bilateral Arm L-Dex Software

    FDA Enforcement
    Class II ·Ongoing·Impedimed Limited·November 1, 2023

    Veradius Unity Mobile Surgery C-arm

    FDA Enforcement
    Class II ·Ongoing·Philips North America·November 15, 2023

    Ziehm Solo. Digital Mobile C-arm

    FDA Enforcement
    Class II ·Ongoing·Orthoscan, Inc.·December 11, 2024

    GE HealthCare OEC 9900 Elite C-arm Systems.

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·September 3, 2025

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021