BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    ESOPHAGEAL BOUGIES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NEXXZR(TM)T AND NEXXZR(TM)S

    FDA 510(k)
    FDA Class 2 ·Dental

    C. DIFF CHEK - 30

    FDA 510(k)
    FDA Class 1 ·Microbiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 23, 2014

    SCREW LOCKING

    FDA Adverse Event
    Injury ·Product code HWC·November 14, 2012

    ATLAS II PLUS DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018