BEUDAMED
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    DARI Health

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197537285·Gregory TC needleholder,for large needle 10mm r...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197087131·Gregory TC needleholder,for large needle 10mm r...

    VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RTM AND OVAL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code ORG·May 1, 2019

    COCR MODULAR HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 3, 2020

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 10, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 20, 2013

    SPECTRANETICS LASER SHEATH II

    FDA Adverse Event
    Death ·SPECTRANETICS CORP.·Product code MFA·July 21, 2011

    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