BEUDAMED
    24 results · 33ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Radiology

    BRILLIANCE VOLUME

    FDA 510(k)
    FDA Class 2 ·Radiology

    PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PLEURX LOCKABLE DRAINAGE LINE SET

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·April 2, 2026

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 16, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008

    PERITX DRAINAGE BAG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·April 3, 2026

    PLEURX DRAINAGE KIT 500ML 10/CS

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·July 25, 2025

    PLEURX DRAINAGE KIT 1000ML

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·January 20, 2026

    PLEURX DRAINAGE KIT 1000ML

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·October 15, 2025

    PERITX DRAINAGE BAG KIT

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·December 18, 2025

    PLEURX DRAINAGE KIT 1000ML

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·September 18, 2025

    PERITX DRAINAGE BAG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·April 11, 2026

    PLEURX DRAINAGE KIT 500ML 10/CS

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·December 24, 2024

    PLEURX DRAINAGE KIT 500ML 10/CS

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·December 24, 2024

    PLEURX DRAINAGE KIT 1000ML

    FDA Adverse Event
    Injury ·CAREFUSION, INC·Product code DWM·February 18, 2025

    PLEURX DRAINAGE KIT 1000ML

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·February 24, 2026

    PLEURX DRAINAGE KIT 1000ML

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·January 17, 2025

    AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter in order to monitor the hydrostatic pressure in the bladder.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·August 22, 2018