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

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    MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756736749·CYSTO PACK

    OCULAR CONNECTION MACHINE(TM)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·July 12, 2023

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·Product code PAH·June 26, 2014

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·January 4, 2013

    INFANT LOW FLOW BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 11, 2010

    Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478

    FDA Recall
    Open, Classified ·DeRoyal Industries Inc·Product code KDD·May 30, 2023