BEUDAMED
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    SECTIONING AID KIT

    FDA 510(k)
    FDA Class 1 ·Pathology

    EasyTouch

    FDA UDI
    MHC MEDICAL PRODUCTS, LLC·MHC18310652·

    SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NIKKISO PARALLEL FLOW DIALYZERS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 23, 2014

    RESTORATION ADM. CUP W/HA

    FDA Adverse Event
    Injury ·STRYKER ORHTOPAEDICS CORK·Product code MEH·November 2, 2012

    ATLAS PLUS VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 19, 2020

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018