BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    AIDE-A-PATIENT (NURSING HOME BED)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Single Use Cytology Brush BC-205D

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    CIMARRON 1000 OR 1000-2

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

    TRILOGY LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D.

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·April 11, 2024

    LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D.

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·February 12, 2024

    OXF ANAT BRG RT LG SIZE 5 PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·December 15, 2017

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2014

    MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code MAF·October 22, 2010

    SMALL BATTERY DRIVE

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HTW·December 29, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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