BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    CORRUGATED FLEX TUBING

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ACCU-CHEK COMFORT CURVE TEST STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VANGUARD ASYMMETRICAL PATELLAR COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AFFINTY THREE BIRTHING BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code HDD·April 11, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·October 31, 2012

    FAST-FIX/IMPLANTS

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW ENDOSCOPY MANUFACTURE·Product code GAT·August 20, 2010

    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