BEUDAMED
    8 results · 19ms · 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.
    Filters Regulation: Us FDA ×

    SYPHILIS BIO-ENZABEAD KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DR. JAPAN FACIL POINT SPINAL NEEDLE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS

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

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 12, 2014

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NEK·October 31, 2012

    PROXIMATE RELOADABLE LINEAR STAPLER - 60 MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·October 29, 2007

    VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 9, 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