BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    OLYMOUS XLS XENON LIGHT SOURCE

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

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110874·TIP GUARDS VENTED GREEN PACK OF 100

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450253182·

    SNOWPOST, SNOWLIGHT

    FDA 510(k)
    FDA Class 1 ·Dental

    5MP MONOCHROME LCD MONITOR, RADIFORCE GX530

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JQX·December 27, 2010

    HYPERFORM

    FDA Adverse Event
    Malfunction ·COVIDIEN (IRVINE)·Product code MJN·July 14, 2015

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·January 11, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 3, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015