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

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    BACTEC DILUTING FLUID

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788223300·Cervical Trial 12x18x14 Lordotic

    FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALLGRAD 45 AND 90 CELL SEPARATION MEDIA

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEPUY ASR XL FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KXA·May 20, 2014

    ROD

    FDA Adverse Event
    Injury ·Product code HSB·November 7, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 5, 2015

    MUST MINI STD CROSS CONNECTOR 37MM - STERILE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKG·September 4, 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

    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

    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