BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    LEAD STYLET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CENTRALOC TIBIAL FIXATION

    FDA UDI
    Biomet Sports Medicine, LLC·00880304421110·

    CONSTI-SSAGE VIBRATOR/MASSAGE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BALL HEADS: BIPOLAR HEAD 28X46

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWY·October 23, 2020

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 28, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·November 12, 2010

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015