BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    MDx-Chex for BCP

    FDA 510(k)
    FDA Class 2 ·Microbiology

    COE®

    FDA UDI
    Gc America Inc.·10386040000703·COE® Regular-Perforated, Individual Tray, #4 Upper

    COE®

    FDA UDI
    Gc America Inc.·D6582600411·COE® Regular-Perforated, Individual Tray, #4 Upper

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690190899·A/P Cutting Block Assy, Open Style Size 1

    Cobbra RF Tissue Dissector

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TRIMED BONE PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CELL-DYN WBC REAGENT A

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·December 12, 2008

    CAPTURE-CMV INDICATOR CELLS

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·September 22, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 1, 2013

    Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X; CE0680DR/(01)H699CE0680DR10Y

    FDA Enforcement
    Class I ·Terminated·Applied Medical Resources Corp·May 13, 2020

    SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016