BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    VITAFLOW SUCTION/ASPIRATION TUBING SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROPIOCEPTOR MASSAGER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·November 24, 2015

    AFFINITY CP PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code KFM·February 7, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 13, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 21, 2014

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    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