BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    BARD TIGER GUIDEWIRE MODEL 000540

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

    ISOPURE LC SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CareView 1500P X-ray Flat Panel Detectors

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 3, 2015

    Z-LOOK3

    FDA Adverse Event
    Injury ·Z-SYSTEMS AG·Product code DZE·February 14, 2013

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·January 17, 2011

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020