BEUDAMED
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    VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NO EQUIPMENT NUMBER

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·October 29, 2024

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code IOR·June 11, 2013

    ULTRAFLEX COVERED TRACHEOBRONCHIAL STENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code JCT·September 17, 2008

    SYNVISC (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·June 3, 2011

    BD PHOENIX¿ NMIC-306

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 10, 2024

    Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD10C; Model Number: 722001; 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 FD10 OR Table; Model Numbers: 722033; 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 FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025