BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    GELSCAN SOFTWARE 2190

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MODEL 50-01-27

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SILGMANN SOLARIUMS-TYPE 1218 CANOPY &

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 28, 2014

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 15, 2012

    ULTRAFLEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code ESW·September 15, 2010

    Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only

    FDA Enforcement
    Class I ·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025