BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    DISTAFLEX

    FDA 510(k)
    FDA Class 1 ·Dental

    OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES

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

    NEOCLOSE HASSON, NEOCLOSE UNIVERSAL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 20, 2014

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 7, 2012

    ST104 TRANSPORT

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIVISION·Product code FPO·August 27, 2010

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    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