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    CEMENT RESTRICTOR

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

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780456711·Integra® Jarit® Obwegeser Retractor, 55mm x 12m...

    FERRIS MODIFIED DISP. IL STERNAL-ILIAC

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM

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

    AFX SYSTEM

    FDA Adverse Event
    Malfunction ·ENDOLOGIX, INC.·Product code MIH·May 30, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 2, 2016

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·June 11, 2015

    Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. Allura Xper FD20 Biplane, Model Number 722008. 5. Allura Xper FD10, Model Number 722010. 6. Allura Xper FD10/10, Model Number 722011. 7. Allura Xper FD20, Model Number 722012. 8. Allura Xper FD20 Biplane, Model Number 722013. 9. Allura Xper FD20 OR Table, Model Number 722023. 10. Allura Xper FD10, Model Number 722026. 11. Allura Xper FD10/10, Model Number 722027. 12. Allura Xper FD20, Model Number 722028. 13. Allura Xper FD20/10, Model Number 722029. 14. Allura Xper FD20 OR Table, Model Number 722035. 15. Allura Xper FD20/20, Model Number 722038. 16. Allura Xper FD20/15, Model Number 722058. 510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025