BEUDAMED
    8 results · 29ms · Sources: EU EUDAMED, US FDA

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    ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.

    FDA 510(k)
    FDA Class 2 ·Radiology

    FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURGICAL MICROSCOPE SYSTEM ORBEYE with IR

    FDA 510(k)
    FDA Class 2 ·Radiology

    SEQUOIA TI POLY SCREW ASSY 6.5MM X 45MM

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code NKB·June 12, 2014

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·December 21, 2012

    AC POWER MODULE

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·November 1, 2010

    Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class I ·Terminated·Covidien·February 11, 2015

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015