BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·November 21, 2013

    VISX EXCIMER LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA LLC·Product code LZS·November 5, 2010

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·August 20, 2013

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·October 30, 2013

    ASR ACETABULAR IMPLANT 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 16, 2013

    CLEARLINK SYSTEM NON-DEHPCONTINU-FLO SOLN SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·April 15, 2011

    UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·June 12, 2008

    MEDISLIM

    FDA Adverse Event
    Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

    1.5MM TI T-PLATE 4 HOLES HEAD/ 8 HOLES SHAFT

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HRS·May 14, 2015

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

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

    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