BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    TRUE BEAM, TRUE BEAM STX, EDGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017736·K-Wire, Double Ended, Trocar Point, Diameter Si...

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193023711·B-P HIP FEMORAL HEAD W/ULTRACOAT - 28 MM + 5 MM

    BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXPRESSEW III W/O HOOK

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code LXH·January 6, 2020

    SPO2 PROBE CONNECTOR

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORP·Product code MHX·January 12, 2015

    SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code OLO·November 19, 2014

    MBT CEM TIBIAL TRAY SZ2.5

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code NJL·May 31, 2013

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·June 15, 2011

    COAGUCHEK XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·August 28, 2008

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·October 8, 2014

    PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 20CM, P/N 0250282006 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