BEUDAMED
    3 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·October 18, 2023

    Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2

    FDA Enforcement
    Class II ·Ongoing·Ambu Inc.·January 17, 2024

    Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures, non-unions or osteotomies.

    FDA Enforcement
    Class II ·Ongoing·TriMed Inc.·February 7, 2024