BEUDAMED
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    LightWalker Laser System Family

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD EMERALD SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL, MEDICATION DELIVERY SOLUTIONS·Product code FOZ·February 14, 2024

    RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COLONRING

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    FDA Adverse Event
    Injury ·NITI MEDICAL TECHNOLOGIES LTD.·Product code FZP·September 2, 2011

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    FDA Adverse Event
    Injury ·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 26, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 22, 2014

    INTERSTIM II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 1, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 25, 2013

    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