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

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    MICROTEK MINI-MAX DRILL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228745351·GC Initial™ Ti Opaqus Dentin ODA4, 50g

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809916493195·Multi-Axial Fenestrated Screw, Ø4.5 x 35mm, Ø6....

    YERSINIA SELECTIVE AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NITROUS OXIDE RECYCLER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 16, 2014

    LIGAMAX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 19, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·December 14, 2012

    OSTYCUT BONE BIOPSY NEEDLE

    FDA Adverse Event
    Injury ·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code DWO·September 7, 2015

    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024