BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    LAS-R BETA LIPOPROTEIN TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    APACERAM BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Double Flexible Tip Wire Guides

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COULTER® ACT 5DIFF CAP PIERCE (CP)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·April 25, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 28, 2007

    SCHANZ SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·September 28, 2012

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024