BEUDAMED
    8 results · 29ms · Sources: EU EUDAMED, US FDA

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    MR 5300 and MR 7700 R11 MR Systems

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·May 5, 2022

    EXTRA LARGE BODY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    XOFT AXXENT CERVICAL APPLICATORS

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 4, 2014

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·July 9, 2013

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026