BEUDAMED
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    OSTEOTOMY BONE STAPLE

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471191938·SHAVER BLADE - AGGR. RESECTOR 5.5MM

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127027543·Low Rider Reamer, Size 55

    SILICONE DUAL LUMEN RADPICC CATHETERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENDURANT II

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·May 23, 2014

    SPEEDBAND SUPERVIEW SUPER 7¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code MND·November 13, 2012

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP. MEDICAL DIVISION·Product code FNL·September 2, 2010

    Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety Notice ( FSN MA-FCO79500316 ) QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products.

    FDA Enforcement
    Class II ·Terminated·Philips Ultrasound, Inc.·December 24, 2014