BEUDAMED
    10 results · 22ms · Sources: EU EUDAMED, US FDA

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    Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Sterile ACIF PEEK

    FDA UDI
    Tyber Medical, LLC·M6958101608750·ACIF- 16mm x 8mm x 7.5 deg PEEK Curved

    ABBOTT AXSYM TROPONIN-I ADV

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CEROX, MODEL 321OF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    EPIC PLUS VR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC. CRMD·Product code LWS·January 13, 2014

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code LZS·June 16, 2011

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 3, 2018

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·May 22, 2018

    Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Synthes USA HQ, Inc.·December 4, 2013