BEUDAMED
    11 results · 20ms · 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.

    REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONVERTORS

    FDA UDI
    Cardinal Health 200, LLC·50885380157873·SmartGown Breathable Surgical Gown, Xlarge

    FORZA

    FDA UDI
    Orthofix US LLC·18257200078110·9MM ROTATING CUTTER

    VisCalor bulk

    FDA 510(k)
    FDA Class 2 ·Dental

    SILVER ALGINATE 11 WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    3M TEGADERM ALGINATE AG SILVER DRESSING

    FDA Adverse Event
    Injury ·3M HEALTH CARE·Product code FRO·June 21, 2016

    SECURE 3 BED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FNL·October 27, 2010

    ELLIPSE DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014

    COULTER® LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code GKZ·December 30, 2012

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 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