BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    BACTIGEN-N. MENINGITIDIS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUANTA FLASH CENTROMERE

    FDA 510(k)
    FDA Class 2 ·Immunology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 21, 2014

    HS HAND CONTROLLED CURVED SHEA

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GEI·November 30, 2007

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM- POSTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·October 29, 2012

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 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