BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    ENDOMYOCARDIAL BIOPSY DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556702717·GC Initial™ MC Powder Opaque OD4, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228701861·GC Initial™ MC Powder Opaque OD4, 20g

    NEUROMOD STIMULATOR MODEL 3723

    FDA 510(k)
    FDA Class 2 ·Neurology

    ELECTRONIC DEPILATORY MODEL 202

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LGW·May 17, 2023

    5F MICROSTICK INTRODUCER SET

    FDA Adverse Event
    Malfunction ·MEDCOMP·Product code DYB·June 5, 2014

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 12, 2012

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 25, 2015

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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