BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    NeuroMatch

    FDA 510(k)
    FDA Class 2 ·Neurology

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250239200·ceraMotion® Zr Chroma Concept Dentin 9, 20g / d...

    EMD THERMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    FibroScan

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLINICAL CHEMISTRY LACTATE DEHYDROGENASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CFJ·May 5, 2017

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 6, 2014

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 15, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013

    Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020