BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    CYGNUS-C Standalone ACIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Opera Evo

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    DUROM US ACETABAR COMPONENT 54/48 N

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·November 3, 2008

    COBAS® AMPLIPREP/COBAS® TAQMAN® HBV TEST, V2.0 CE-IVD

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS·Product code MKT·August 24, 2011

    CLINITRON RITEHITE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code INX·July 3, 2013

    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013