BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    MED-CARE EMERGENCY SHEARS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PROCARE PLUS VITRECTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code OUT·May 20, 2014

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code FZP·October 30, 2007

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 2, 2012

    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