BEUDAMED
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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Enforcement
    Class II ·Ongoing·Nexstim PLC·June 14, 2017

    Amplatz Extra Stiff Whisker Wire Guide

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 21, 2018

    Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019

    3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.

    FDA Enforcement
    Class II ·Terminated·3M Company/3m Espe Dental Products·September 4, 2013

    Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID. 4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID. 5. SESK MAIMONIDES HOSPITAL SPINAL/EPIDURAL. 6. SESK OU MEDICAL CENTER - SPINAL/EPIDURAL. 7. SESK ELLIS HOSPITAL - SPINAL EPIDURAL. 8. STONY BROOK HSP SPINAL EPIDRAL TRAY SESK. 9. SESK UAB SPINAL EPIDURAL. 10. SESK CREIGHTON UNIV BMH SOINAL EPIDURAL. 11. SESK, BSW SPINAL EPIDURAL TRAY. 12. LYNDON B JOHNSON HOSPITAL SPINAL EPID.

    FDA Enforcement
    Class II ·Ongoing·B BRAUN MEDICAL INC·October 15, 2025

    Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK EAST JEFFERSON GEN HOSP 20071769. 3. CESK FLETCHER ALLEN HOSPITAL. 4. CESK WASHOE MEDICAL CENTER. 5. CESK DETROIT MEDICAL CTR 20064586. 6. CESK ALBANY MEDICAL CENTER. 7. CESK EPIDURAL BLOCK TRAY. 8. CESK, BSW EPIDURAL TRAY. 9. CESK HOWARD COUNTY GENERAL. 10. CESK CE17TKFC10L. 11. CESK WILLIAMSON MEDICAL CENTER. 12. CESK FLORIDA HOSPITAL. 13. CESK RIVERSIDE HEALTH SYSTEM. 14. CESK MAYO CLINIC OB. 15. CESK PRESBYTERIAN HOSPITAL DALLAS. 16. CESK HOUSTON METHODIST HOSPITAL. 17. CESK OHIO STATE UNIV MEDICAL CENTER. 18. CESK NORTONS WOMEN'S AND CHILDREN'S. 19. CESK BEN TAUB. 20. CESK PENN MEDICINE CONTINUOUS-ORIG CUST. 21. CESK ALLEGHENY GENERAL HOSPITAL. 22. CESK UNIVERSITY OF ILLINOIS MED CTR. 23. CESK RUSH UNIVERSITY MEDICAL CENTER. 24. CESK ST. JOSEPH MEDICAL CENTER. 25. CESK INTEGRIS HEALTH. 26. CESK UMASS MEMORIAL. 27. CESK STANFORD UNIV HOSP 20054718. 28. CESK OVERLAKE HOSPITAL. 29. CESK CHRIST HOSPITAL 20057985. 30. CESK NEWTON-WELLESLEY HOSPITAL.

    FDA Enforcement
    Class II ·Ongoing·B BRAUN MEDICAL INC·October 15, 2025