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

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    CARDIAC OUTPUT COMPUTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110683·LUER ADAPTOR FOR IRRIGATION

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0606000·Tray, Base, 6"

    Inertia® CONNEXX™ Modular Pedicle Screw System

    FDA UDI
    NEXXT SPINE, LLC·00889929047002·Straight Rod, Ø6.0x600 mm

    DYNATECH MR 5000, CATALOG #011-976-0600

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Freedom Spinal Cord Stimulator System

    FDA 510(k)
    FDA Class 2 ·Neurology

    PROSTHESIS, PATELLAR ARTICULAR SURFACE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LTJ·June 12, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·December 19, 2013

    XIA II LP MODULAR TAP 5,5MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code LXH·July 9, 2010

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025