BEUDAMED
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    The Nellcor pulse oximetry monitor interface cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PINNACLE MTL INS NEUT36IDX50OD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 17, 2013

    RESERVOIR 1.8 ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FRN·June 17, 2011

    ECHELON 60 ENDOPATH STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·September 22, 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