BEUDAMED
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    REVISED LABELING FOR SYVA METHADONE ASSAYS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INFANT CARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TDK ECG ELECTRODE MEL-08

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CELLEX

    FDA Adverse Event
    Malfunction ·THERAKOS·Product code LNR·May 29, 2014

    CARDIFIX

    FDA Adverse Event
    Injury ·GUIDANT ANGLETON/ST. PAUL·Product code NVN·October 19, 2010

    COULTER® ACT DIFF HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·December 14, 2012

    BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·January 30, 2019

    Philips Zenition 50, Model Number: 718096

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024