BEUDAMED
    71 results · 7ms · Sources: EU EUDAMED, US FDA

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

    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·April 19, 2023

    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·April 19, 2023

    Cirq Arm System 2.0

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

    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

    LITe Decompression Snake Arm, REF 48080230

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

    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

    GE HealthCare OEC 9900 Elite C-arm Systems.

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

    Integra Universal Flexible Arm part number REF 1362275

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

    Zenition 50 & 70 Mobile Surgery C-arm

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

    Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.-Boxborough·June 24, 2026

    O-arm O2 Imaging System. Mobile X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.-Boxborough·July 16, 2025

    HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)

    FDA Enforcement
    Class II ·Ongoing·The Magstim Company Limited·February 20, 2019

    Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 22, 2023

    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

    LFS Flat screen arm system with 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 Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFSST2323TV, LFSLFSST2323, LDFSLFSLED7TV5, LDFSLFSLED7TV55, LFSLED55, LFSLFSST23, LFSST2923TV, LFSST29TV, LFSST29, LFSST19WC, LFSST2923, LFSLFSST-1, LFSST292323, LFSST1919WC, LFS ST2319WC

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

    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

    BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.

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