BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    RICH-MAR MODEL V ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EZ PASS

    FDA UDI
    Biomet Orthopedics, LLC·00880304563728·

    EZPass™

    FDA UDI
    Biomet Orthopedics, LLC·00887868511004·

    Various trauma and sports medicine instruments and implants. Passer.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 1, 2016

    MOORE TYPE ENDO PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SHEER THIN AROMAS YELLOW LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 25, 2014

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 9, 2015

    HS 111 PROXIMAL SEAL SYSTEM 4.3MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·January 3, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014

    EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HWQ·April 15, 2014