BEUDAMED
    8 results · 32ms · Sources: EU EUDAMED, US FDA

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    CERTEX OCT SPINAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2024

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

    ARCHITECT IPTH

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code CEW·June 18, 2011

    PERFLUORON

    FDA Adverse Event
    Malfunction ·ALCON - FORT WORTH/ ALCON LABORATORIES, INC.·Product code LWL·August 22, 2008

    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