BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HANAROSTENT ESOPHAGUS (CCC)

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

    Omnichroma Flow

    FDA 510(k)
    FDA Class 2 ·Dental

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 25, 2014

    1020279-2013-00006

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·January 2, 2013

    CLEARLINK LUER ACTIVATED VALVE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE-CARTAGO·Product code FPA·August 22, 2016

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

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

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