BEUDAMED
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    Epic Pro

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

    ADVANCE SPIKED POROUS TIBIAL BASE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    TRIDENT PLST INS IMP TIP 32MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·June 11, 2013

    EASYTRAK 3

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 15, 2011

    EEA 31MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GDW·September 16, 2008

    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

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