BEUDAMED
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    ARTIS ZEE/ZEEGO SW VC21

    FDA 510(k)
    FDA Class 2 ·Radiology

    CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BD INSYTE AUTOG BC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 27, 2024

    BD INSYTE AUTOG BC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 26, 2024

    BD INSYTE AUTOG BC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 26, 2024

    BD INSYTE AUTOG BC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 26, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    ETHICON, INC.·Product code GAM·June 17, 2011

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021