BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    VisAble.IO

    FDA 510(k)
    FDA Class 2 ·Radiology

    StealthStation Cranial Software v1.3.2

    FDA 510(k)
    FDA Class 2 ·Neurology

    PICCOLO TRIGLYCERIDES TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    LIBERTY CYCLER

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·October 31, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 25, 2011

    AMPHIRION DEEP PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·INVATEC SPA·Product code DQY·July 12, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026