BEUDAMED
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    A1 SYSTEME 8201/2

    FDA 510(k)
    FDA Class 2 ·Hematology

    E-LINE

    FDA UDI
    Richard Wolf GmbH·04055207010112·CUTTING ELECTRODE MONO 16FR 0° for resectoscop...

    INSULCLOCK® v2.0 PRO

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTM·May 30, 2014

    TI MATRIX LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code NKB·November 21, 2012

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 8, 2015

    Presource PBDS, Kit, Common. 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