BEUDAMED
    10 results · 29ms · Sources: EU EUDAMED, US FDA

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    VWF-IX:AG CONTROL PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    UltraClip® II Breast Tissue Marker

    FDA UDI
    Bard Peripheral Vascular, Inc.·00801741032271·ULTRACLIP® II breast tissue marker 17g x 12cm ...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694025409·EnCompass 17mm Reamer

    AUTO TOTAL PROTEIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VIVA XT

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·October 4, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·November 2, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    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