BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    SimpliFix Hip System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573020133·INTRG WHISP-Z ROTH CUS-11T +5A 018 LR

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776198206·Bergstrom SMBN Skeletal Muscle Biop

    JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810

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

    BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI

    FDA 510(k)
    FDA Class 2 ·Immunology

    STAT DL 9.5 FR. 40 CC. IAB

    FDA Adverse Event
    Death ·DATASCOPE CORP.·Product code DSP·January 28, 1998

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 31, 2011

    GRANFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Death ·MPRI·Product code LWS·July 16, 2013

    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).

    FDA Enforcement
    Class II ·Ongoing·SenTec AG·September 27, 2023