BEUDAMED
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    Venue

    FDA 510(k)
    FDA Class 2 ·Radiology

    COMMUNIFY PACS VIEWER

    FDA 510(k)
    FDA Class 2 ·Radiology

    TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222D

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    36MM 12/14 TPR FEM HD STD NK

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·August 29, 2018

    EXCEED ABT 3HL SHELL 48/60MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDD·August 29, 2018

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 27, 2022

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 30, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 23, 2011

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS INC·Product code LZG·July 11, 2013

    GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 28, 2014