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

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    PRISMA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MOUTHPIECE SEAL

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    iNSitu Bipolar Hip System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 5, 2014

    KAPPA 400 DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·October 15, 2012

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·August 6, 2010

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PROPONENT DR SL (Model L201)

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