BEUDAMED
    14 results · 18ms · Sources: EU EUDAMED, US FDA

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    NIPRO SAFELET CATH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Acrometrix BKV High Control

    FDA UDI
    Microgenics Corporation·00884883006409·

    NuVasive® Interfixated Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECIMEN RETRIEVAL SYSTEM

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

    NexGen® Legacy®

    FDA UDI
    Zimmer, Inc.·00889024445871·

    NexGen® Legacy®

    FDA UDI
    Zimmer, Inc.·00889024445857·

    NexGen® Legacy®

    FDA UDI
    Zimmer, Inc.·00889024445864·

    NexGen® Legacy®

    FDA UDI
    Zimmer, Inc.·00889024445833·

    NexGen® Legacy®

    FDA UDI
    Zimmer, Inc.·00889024445840·

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code ITI·February 13, 2013

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·January 13, 2011

    HEARTMATE II LEFT VENTRICULAR ASSIST DRIVE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·July 17, 2014

    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