BEUDAMED
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    AbbVie NJ

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Equator

    FDA UDI
    Preat Corporation·00842092179819·Equator Abutment for Astra EV 3.6 x 3mm

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383553490·Gutta Percha Points is used to root canal filin...

    IXL-II DIABETES MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DISPOSABLE BLOOD PRESSURE CUF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OCTRODE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013

    STAIR PRO - MODEL 6252

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPP·June 20, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·November 25, 2020

    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

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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