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

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    Revogene

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LifeGlobal Group, LLC

    FDA registration
    LifeGlobal Group, LLC·4 products·🇺🇸 United States

    Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing

    FDA 510(k)
    FDA Class 2 ·Hematology

    OTI UNICONDULAR INTERPOSITIONAL SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024

    HELICAL BLADE INSERTER

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code LXH·November 4, 2014

    VASOVIEW 6 EVH SYSTEM

    FDA Adverse Event
    MAQUET CARDIOVASCULAR, LLC.·Product code GEI·August 10, 2011

    IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MTF·July 12, 2013

    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