BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Yarlap II

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ONLINE TDM PROCAINAMIDE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO·Product code DTB·June 10, 2014

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·December 5, 2012

    UNIVERSAL IMPACTOR/POSTIONER

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MAY·June 22, 2015

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014