BEUDAMED
    14 results · 34ms · Sources: EU EUDAMED, US FDA

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    NANOBONE / GRANULATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARTHREX TRIMIT FAMILY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REAVILLMED PRESSURE MONITORING SYSTEM AND PICC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 3, 2014

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011

    UNSPECIFIED PRIMARY PLUM SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·October 3, 2024

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRE·September 14, 2020

    UNSPECIFIED PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·November 24, 2024

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Death ·COOK VANDERGRIFT INC·Product code DRE·July 12, 2019

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Death ·COOK VANDERGRIFT INC·Product code DRE·September 17, 2020

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Death ·COOK VASCULAR INC·Product code DRE·May 9, 2019

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·September 30, 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