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

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    1688 4K Camera System with Advanced Imaging Modality

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257129906·30-40 MV FOR MEN CLSC EW STD TAN IV

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257128169·30-40 MV FOR MEN SEL EW CLF STD TAN IV

    BILIRUBIN ASSAY ON THE OMNI S ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIA-ROOT BIO MTA

    FDA 510(k)
    FDA Class 2 ·Dental

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 24, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011

    21MM X 5.5MM OSC. MICRO BLADE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026