BEUDAMED
    9 results · 35ms · Sources: EU EUDAMED, US FDA

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    HPR HOME PATIENT RENATRON

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

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331140518·fischer tonsil knife & dissector, 15.0 mm curve...

    URIC ACID REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code KNK·April 15, 2011

    21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPR SYSTEM

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

    OPTIBOND XTR

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code KLE·May 27, 2014

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·November 15, 2012

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2015

    Presource PBDS, Kit, No Spiro Diabetes. 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