BEUDAMED
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    HELENA REP GEL PROCESSOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Modulus

    FDA UDI
    Nuvasive, Inc.·00887517023841·Modulus ALIF Trial, 10x38x30mm 10° Large

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331127830·hohmann-mini retractor, 6 1/2" (16.5 cm), 8.0 m...

    Shear Stress Therapeutics SST 3000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FLOWMEDICA BENEPHIT INFUSION SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSE GEN MODEL 102

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·June 18, 2014

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR

    FDA Adverse Event
    Injury ·MINNTECH CORPORATION·Product code KOG·October 25, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 20, 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