BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CONSTRUX MINI PEEK TI SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CS 7600

    FDA 510(k)
    FDA Class 2 ·Dental

    CVC SET: 2-LUMEN 8FR X 2 0CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code FOZ·June 14, 2013

    GAMMAMEDPLUS AFTERLOADER HDR

    FDA Adverse Event
    Malfunction ·VARIAN MEDICAL SYSTEMS BRACHYTHERAPY·Product code JAQ·July 25, 2011

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·September 30, 2008

    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013