BEUDAMED
    9 results · 36ms · Sources: EU EUDAMED, US FDA

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    Vision 2, EVARVision, TrackVision 2, HeartVision 2

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMMULITE 2000 ALLERGEN-SPECIFIC IGE

    FDA 510(k)
    FDA Class 2 ·Immunology

    VITESSE 3.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·August 16, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013

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

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

    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