BEUDAMED
    27 results · 25ms · Sources: EU EUDAMED, US FDA

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    Erchonia Violet ZERONA® Z6 OTC

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

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750004577·VITROS Chemistry Products Performance Verifier II

    SC TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARTHREX DISTAL RADIUS PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 17, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·November 3, 2025

    TRUENESS

    FDA Adverse Event
    Injury ·SINOCARE INC·Product code NBW·October 15, 2025

    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 23, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC.·Product code NBW·November 28, 2025

    TRUENESS

    FDA Adverse Event
    Injury ·SINOCARE INC ADDRESS LINE 1 NO.265 GUYUAN·Product code NBW·October 20, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·May 29, 2026

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·March 11, 2026

    TRUENESS AIR

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·February 26, 2026

    VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

    FDA Enforcement
    Class III ·Ongoing·Ortho Clinical Diagnostics Inc·November 25, 2020

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·October 20, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·November 19, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC.·Product code NBW·October 10, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·April 28, 2026