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

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    WILLIAMS BELT & BOOT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube

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

    BTI DENTAL IMPLANT 5.5-6.5

    FDA 510(k)
    FDA Class 2 ·Dental

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 31, 2014

    GAMMA

    FDA Adverse Event
    Malfunction ·DRAEGER MEDICAL SYSTEMS, INC. (IT/M)·Product code MHX·November 3, 2010

    S3 EX - 3005

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·November 29, 2012

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

    VIDAS® ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·June 3, 2021

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    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