BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Infrared Thermometer TET-351

    FDA 510(k)
    FDA Class 2 ·General Hospital

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025033·G95 Mini Incubator

    8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535

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

    SPEAC System

    FDA 510(k)
    FDA Class 2 ·Neurology

    APEX MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·November 3, 2008

    UNKNOWN NEXGEN KNEE

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·August 16, 2011

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023

    Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

    FDA Enforcement
    Class III ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025