BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    STRYKER POWERED STRETCHER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·ACUMED LLC·Product code HRS·December 27, 2019

    BIOSURE REGENESORB interference Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    7.0MM TI CLICKX PEDICLE SCR PREASSEMBLED 45MM THRD LENGTH

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·February 5, 2013

    DEXTRUS 4136

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·December 23, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 17, 2014

    INFUSOMAT SPACE PUMP IV SET

    FDA Adverse Event
    Malfunction ·B. BRAUN DOMINICAN REPUBLIC·Product code FPA·November 17, 2009

    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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026