BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    DENTAL CEMENT, ZINC PHOSPHATE

    FDA 510(k)
    FDA Class 2 ·Dental

    Zio XT ECG Monitoring System, Zio AT ECG Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PORTABLE CARDIAC MONITOR, ABBY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·May 5, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012

    IMMULITE 2500

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JJQ·August 3, 2010

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018