BEUDAMED
    12 results · 32ms · Sources: EU EUDAMED, US FDA

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    BED GUARD

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

    MM-SEAL

    FDA 510(k)
    FDA Class 2 ·Dental

    AMSINO TRACHEOSTOMY CARE TRAY

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

    SHELL WITH MULTI HOLES POROUS 58 MM O.D. SIZE LL FOR USE WITH LL LINERS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·May 13, 2021

    MODULAR NECK X 12/14 NECK TAPER USE WITH +0 HEADS ONLY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·May 13, 2021

    MODULAR FEMORAL STEM PRESS-FIT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·May 13, 2021

    UNKNOWN LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·May 13, 2021

    HIRES 90K IMPLANT

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·February 19, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 7, 2012

    SECURE II MED/SURG BED

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

    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