BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    SLAVE MONITORS DC109 & VS109

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Diode Laser Therapy Systems

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BROVIAC 2.7 FR SL CVC CUTDOWN TRAY W/SURECUFF TISSUE

    FDA Adverse Event
    Injury ·C.R. NARD, INC. (BASD)·Product code LJS·April 29, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC., USA·Product code LFR·October 12, 2007

    CEMENT

    FDA Adverse Event
    Injury ·Product code LOD·October 31, 2012

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

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