BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Sleepiz One+

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ponto

    FDA UDI
    Oticon Medical AB·05712149026517·PONTO 5 SUPERPOWER, TC

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113974·HYDRO-DISSECT CANNULA 25GA ANGLED 8MM

    NEUROPACE BURR HOLE COVER MODEL 8110

    FDA 510(k)
    FDA Class 2 ·Neurology

    LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    DRILL FLEXIBLE CANNULATED 7.5MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code NBH·June 2, 2020

    CURRENT RF DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    CONTOUR TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·August 16, 2011

    MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 12, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018