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

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    Whitsundays Mask System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPEEDTRAP

    FDA UDI
    Medos International Sàrl·10886705027149·SPEEDTRAP Graft Preparation System WHITE 30 mm

    Non-Contact Forehead Thermometer (Models UT306H & UT308H)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHASEAL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DURATA STS OPTIM ACTIVE FIXATION

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

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·August 25, 2011

    ACRYSERT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·July 10, 2013

    MENTOR SILTEX ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·October 18, 2018

    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

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

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