BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    RINSE MACHINE KR-4 KIDNEY RINSE-4

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula

    FDA 510(k)
    FDA Unclassified ·Unknown

    CARESITE SMALL BORE EXTENSION SETS

    FDA Adverse Event
    Malfunction ·B. BRAUN OF DOMINICAN REPUBLIC·Product code FPA·March 21, 2014

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·November 23, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 17, 2015

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015