BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    ONVOY™ Acetabular System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694023306·FPS Calcaneal Plate, 56mm

    CALFIX, LOCKING CALCANEAL PLATE, 56MM

    FDA Adverse Event
    Injury ·OSTEOMED·Product code HRS·March 6, 2014

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694078122·FPS 3.5/4.0 56mm Calcaneal Plate Sterile Qty 2

    MODIFICATION TO SOAKER CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Straumann CARES M-Series CAD/CAM System

    FDA 510(k)
    FDA Class 2 ·Dental

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 11, 2014

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 12, 2011

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·July 23, 2013

    PKG, MINI METZENBAUM SCISSORS, CURVED LONG, P/N 0250080266. 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