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

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    ORBITAL TISSUE EXPANDER (OTE)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CS 7600 Smart Plate

    FDA UDI
    CARESTREAM HEALTH, INC.·60889971060150·50PC CS7600 SMART PLATE SIZE 3 V2 BULK

    SPACELABS HEALTHCARE

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522123337·BLADDER COVER,ABP,X-LRG,38-50 CM,QUICK DISC

    UD-1000 ULTRASONIC A/B SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTM·April 11, 2013

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 15, 2011

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 17, 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

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024