BEUDAMED
    12 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.

    HI-PHORE HIGH RESOLUTION ELECTROPHORES

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CODMAN® ACCU-FLO®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780517511·CODMAN® ACCU-FLO® Distal Slit Valve Barium Cath...

    CODMAN® ACCU-FLO®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780536833·CODMAN® ACCU-FLO® Distal Slit Valve Barium Cath...

    CODMAN ACCU-FLO

    FDA UDI
    Cerenovus, Inc.·10886704040323·CODMAN ACCU-FLO Distal Slit Valve Barium Cathet...

    VBR™ vertebral body replacement

    FDA UDI
    Ulrich GmbH & Co. KG·04052536076130·VBR end piece, size S, left, 0°

    MOBILE C-ARM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Neuspera Nuity System

    FDA 510(k)
    FDA Class 2 ·Neurology

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 6, 2012

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP. MEDICAL DIVISION·Product code FNL·August 26, 2010

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 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