BEUDAMED
    15 results · 38ms · Sources: EU EUDAMED, US FDA

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    MICRO & MINI-MICRO ALLIGATOR FORCEPS

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788223690·Cervical Rasp + DS 6x12x12 Flat

    COMFORT WINDJOY SCOOTER, MODEL LY-EW302

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PURE Laser

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

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·June 11, 2020

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·August 14, 2020

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2014

    PLASMABLADE TISSUE DISSECTION DEVICE

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012

    HARMONIC ACE 23 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·August 17, 2007

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·December 21, 2016

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·August 11, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·June 27, 2019

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·July 16, 2019

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    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