BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    Argen Clear Aligner, Argen Clear Aligner Premium

    FDA 510(k)
    FDA Class 2 ·Dental

    AIRVO SERIES HUMIDIFIERS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·March 2, 2023

    FOLFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 24, 2014

    ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code KOG·November 8, 2010

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 28, 2012

    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