BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    SIGMA II - DUAL PLACE HYPERBARIC CHAMBER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Avalon Fetal Monitor FM20

    FDA UDI
    Philips Medizin Systeme Böblingen GmbH·00884838000407·Avalon FM20 Fetal Monitor for external Fetal Mo...

    GFS Ultimate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SUNSPOTS PRE-GELLED SURFACE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    CAPSUREFIX

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 10, 2014

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 8, 2010

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·December 7, 2012

    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·October 19, 2016

    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