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

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    Filters Regulation: Us FDA ×

    HIGH PRESSURE CONNECTING SETS, MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)

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

    7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    8110 ALARIS SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 11, 2021

    SIMPLE PREP CARBIDE

    FDA Adverse Event
    Injury ·COLTENE WHALEDENT INC.·Product code EJL·February 3, 2022

    UNKNOWN SUTURE PRODUCT

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAW·November 30, 2010

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·December 7, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 6, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015