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

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    MEDICA IIF-ANTI-THYROID ANTIBODY TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO: CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD CTGCTV2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 2, 2014

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 23, 2012

    NOT APPLICABLE (INCIDENT OCCURRED IN BCI WAREHOUSE)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 24, 2010

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015