BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    UNIVERSAL FEMORAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOMERIEUX RSV DIRECT IF KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    URODYNAMIC MEASURING SYSTEM

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

    SUPER POLIGRIP ORIGINAL

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOL·November 18, 2010

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 14, 2013

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 3, 2014

    PKG, RING HANDLE, P/N 0250080236. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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