BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    Modular Rotating Hinge Knee Systems and Compatible Components

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    HydroMID

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TIMEX DIGITAL ORAL THERMOMETERS; TIMEX ACCUCURVE ORAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NEXTAR SPINE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 10, 2011

    11.0MM TI TROCH FIXATION NAIL SCREW/95MM - STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HSB·November 4, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 12, 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