BEUDAMED
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    RENAMEL ESTHETIC RESTORATIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209133451·

    FOCUS UREA NITROGEN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    ABX MINOTROL 16

    FDA Adverse Event
    Other ·HORIBA MEDICAL·Product code GKZ·June 6, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 6, 2014

    SECURA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·October 5, 2010

    ALLEGRO TOPOLYZER VARIO

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code MMQ·November 30, 2012

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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