BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    HEMOGLOBIN A2 TESTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    Straumann CARES M-Series CAD/CAM System

    FDA 510(k)
    FDA Class 2 ·Dental

    NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BD PHASEAL¿ INFUSION SYSTEM ADAPTOR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·October 18, 2018

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 28, 2018

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·April 24, 2014

    08290-8418-01

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code FMF·September 27, 2012

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 28, 2010

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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