BEUDAMED
    22 results · 22ms · Sources: EU EUDAMED, US FDA

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    ORTHOLOC® 3Di Small Bones Plating

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMITH & NEPHEW RADIOPAQUE TRIAL NECKS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    KYPHON XPEDE BONE CEMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·December 21, 2018

    KYPHON XPEDE BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·May 29, 2019

    LINEAR? ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 9, 2025

    KYPHON XPEDE BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019

    KYPHON XPEDE BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019

    1030489-2019-01511

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·December 31, 2019

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·October 10, 2014

    STEP DRILL, 2.4MM/3.0MM TISSUETAK/BIO-SUTURETAK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HTW·July 15, 2011

    POLYFORM SYNTHETIC MESH

    FDA Adverse Event
    Injury ·PROXY BIOMEDICAL LTD.·Product code FTL·May 28, 2013

    1030489-2019-01423

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 10, 2025

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·CARDIAC SURGERY MFG KERKRADE·Product code NDN·September 8, 2021

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·July 22, 2022

    KYPHON XPEDE BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·January 16, 2020

    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·December 2, 2020

    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·December 2, 2020

    Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·August 19, 2020