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

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    P.F.C. CERAMIC HIP HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORTHO

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750005338·ORTHO® HBc ELISA Test System

    MINI TIGHTROPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIFEPAK 12, 20, 500, CR PLUS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 22, 2015

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 29, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 2014

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·December 10, 2018

    ORTHO HBC ELISA TEST SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code LOM·May 3, 2021

    ORTHO HBC ELISA TEST SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code LOM·May 3, 2021

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

    FDA Enforcement
    Class I ·Terminated·BioMedical Equipment Service Co (BMES)·August 18, 2021