BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    SUPRAMID EXTRA SUTURES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EZ PASS

    FDA UDI
    Biomet Orthopedics, LLC·00880304563735·

    EZPass™

    FDA UDI
    Biomet Orthopedics, LLC·00887868511011·

    QUATTRO CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LENSX 550 LASER SYSTEM. MODEL 550

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    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

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 9, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·November 12, 2010

    OT PING 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