BEUDAMED
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    COLIGN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102145·BLUMENTHAL CONJUNCTIVA DISSECTOR

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587P13112470·13mm PLIF Implant 11mm Wide 24mm Length, 7 deg ...

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613153992707·Posterior Stabilized Tibial Insert

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·August 20, 1999

    ALN OPTIONAL VANA CAVA FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code ORG·March 5, 2019

    ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT

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

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Injury ·ALCON-IRVINE TECHNOLOGY CENTER·Product code HQC·May 23, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011

    MBT CEM KEEL TIB TRAY SZ2.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, DEPUY CORK DIVISION·Product code NJL·August 20, 2008

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code NKM·March 7, 2024

    Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; 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

    Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; 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

    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). 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 17. Allura Xper FD20/15 OR Table, Model Number 722059.

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