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

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    WALK-A-CYCLE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ENTRY REAMER

    FDA UDI
    Biomet Orthopedics, LLC·00887868048081·

    WALLACH LOOP ELECTRODE

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

    NON-CONTACT THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    K 520711-2, Hercep Test, 35Test, HER2, Protein

    FDA Recall
    Terminated ·Dakocytomation California Inc·Product code MVC·September 29, 2005

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·May 1, 2014

    VIPER 2 X-TAB CANNULATED SCREW 6X50MM TI 2810

    FDA Adverse Event
    Injury ·DEPUY RAYNHAM·Product code NKB·November 6, 2012

    SCULPTRA

    FDA Adverse Event
    Injury ·SANOFIAVENTIS U.S. LLC·Product code LMH·August 27, 2010

    PFNA-II BLADE L75 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HSB·June 23, 2023

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    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