BEUDAMED
    5 results · 14ms · Sources: EU EUDAMED, US FDA

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    illumina Model NextSeq 550 Dx REF 20005715

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·May 3, 2022

    illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·May 3, 2022

    illumina Model NextSeq 550 Dx REF 20005715

    FDA Enforcement
    Class II ·Completed·Illumina, Inc.·June 22, 2022

    Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010

    FDA Enforcement
    Class II ·Completed·Aesculap Implant Systems LLC·July 27, 2022

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020