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    MAX-I-GRASP

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

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209135653·

    HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8

    FDA 510(k)
    FDA Class 2 ·Hematology

    FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD ECLIPSE 21G X 1.25" BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Injury ·BD·Product code JKA·May 28, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 5, 2010

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    FDA Adverse Event
    Injury ·MEDTRONIC, INC·Product code NEK·November 27, 2012

    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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012