BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    DSS Sinusplasty Balloon Catheter

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Headless Compression Screw

    FDA UDI
    I.T.S. GmbH·09120047299074·Headless Compression Screw, Cannulated, D=4.3mm...

    CREODENT SOLIDEX CUSTOM ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    H-WAVE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 6, 2014

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 3, 2011

    TECNIS

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQL·September 6, 2018

    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    UNID ROD

    FDA Adverse Event
    Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

    UNID ROD

    FDA Adverse Event
    Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HWC·January 23, 2026