BEUDAMED
    10 results · 24ms · Sources: EU EUDAMED, US FDA

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    Phoenix ICON, Phoenix ICON GO

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Med Spec Boxer Splint

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357235759·

    MAMMOWORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONCERT CRANIOPLAST

    FDA 510(k)
    FDA Class 2 ·Neurology

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·August 5, 2014

    PROFEMUR(R) MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·August 25, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·July 24, 2014

    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