BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MaxBlend 2, MaxBlend Lite

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INNOVACON SPECTRUM II TEST CARD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SYNCHROMED

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LKK·May 21, 1999

    SYNCHROMED II

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LKK·June 3, 2013

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·September 21, 2007

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 28, 2014

    ENRHYTHM DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010

    BRILLIANCE 64 AIR

    FDA Adverse Event
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·December 3, 2012

    ISOMED

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·August 15, 2012

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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