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

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    RAICHEM LDH-L REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STRADIS HEALTHCARE

    FDA UDI
    STRADIS MEDICAL, LLC·M75268223120·

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113584·PS-C Insert, Size 3 x 12mm

    Integra Expandable Interbody

    FDA UDI
    Seaspine Orthopedics Corporation·10889981049263·IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG. T...

    SeaSpine Expandable Interbody

    FDA UDI
    Seaspine Orthopedics Corporation·10889981123482·IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG

    ON-Q C-BLOC

    FDA Adverse Event
    Other ·I-FLOW CORP.·Product code MEB·June 4, 2008

    PICCOLO PHOSPHORUS TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RayStation 12A

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2014

    ENDOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE 12MM DIAMETER 100MM SLEE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code GCJ·December 6, 2007

    PLASMABLADE TISSUE DISSECTION DEVICE

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012

    GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012