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

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    Phantom Fibula Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JuggerKnot Soft Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mobility Scooter (Models: W3431D)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2025

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 30, 2011

    REPLY

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code NVZ·November 7, 2014

    XENFORM

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·July 16, 2013

    Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025