BEUDAMED
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    MODEL ELI-100/ST ELECTROCARDIOGRAPH

    FDA 510(k)

    SOMATOSENSORY EVOKED POTENTIAL STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    INTRO-REDUCER (NASOGASTRIC TUBE)

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

    ML-HD MOD CALC PROX 34B

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·June 25, 2014

    PROSTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code KNS·January 3, 2013

    ASKU

    FDA Adverse Event
    Death ·MEDTRONIC MILACA INC.·Product code DTE·November 10, 2010

    Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.

    FDA Enforcement
    Class II ·Terminated·Navilyst Medical, Inc., an AngioDyamics Company·June 22, 2016