BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    HANDI-TRAY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MODIFICATION TO MONARCH SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XENX STONE MANAGEMENT DEVICE

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

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 1, 2014

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·November 7, 2012

    BV PULSERA

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code IZI·August 27, 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