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

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    TRAY, SUTURE REMOVAL

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

    Philips IntelliSite Pathology Solution

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838124325·Whole Slide Imaging System. The device is an au...

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110645·COAXIAL IRR-ASP TIP STR W/SILICONE 0.4MM

    Daytona

    FDA UDI
    Seaspine Orthopedics Corporation·10889981131647·Closed Lateral Connector, 4.5 x 4.5 x 45mm

    NuVasive® Interfixated Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECIMEN RETRIEVAL SYSTEM

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

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    FDA Adverse Event
    Injury ·CYTYC SURGICAL PRODUCTS·Product code MNB·March 23, 2007

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 18, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·July 9, 2010

    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

    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 Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·October 21, 2013

    Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·October 3, 2012