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

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    GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters

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

    HOVEROUND TEKNIQUE, MODEL HD-6

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SINUS QUICK IT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·September 24, 2019

    ARTICULEZE M HEAD 36MM +12

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 25, 2013

    AEQUALIS STEM FOR FRACTURE D.6.5 HA-COATED

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·January 5, 2026

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 2, 2008

    UV FLASH TRANSFER SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 26, 2013

    ABL800

    FDA Adverse Event
    Malfunction ·RADIOMETER MEDICAL APS·Product code CHL·January 11, 2007

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

    BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020