BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Sterile and Non-Sterile Ultrasonic Coupling Agent

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDENTIKA ABUTMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO: CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 9, 2023

    GMK REVISION TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2025

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 9, 2011

    CONCERTO CRT-D DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NIK·November 13, 2008

    3.5MM CORTEX SCREW SELF-TAPPING 28MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·July 23, 2013

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

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