BEUDAMED
    9 results · 33ms · Sources: EU EUDAMED, US FDA

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    AUTOMATED BLOOD CELL SEPARATOR

    FDA 510(k)
    FDA Class 2 ·Hematology

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788225210·Cervical Trial 10x18x14, 12 deg Lordotic

    EasyTouch

    FDA UDI
    MHC MEDICAL PRODUCTS, LLC·MHC18225212·ET 25G 1 in 1mL Low Dead Space FlipLock Syr

    BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON

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

    PREVENT SEAL

    FDA 510(k)
    FDA Class 2 ·Dental

    PROMUS ELEMENT? PLUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 21, 2014

    SYNCHRO²¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·November 7, 2012

    DUR MAR 10D LINER 28IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·August 27, 2010

    Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018