BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D

    FDA 510(k)
    FDA Class 2 ·Neurology

    SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 23, 2011

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 5, 2013

    NOVATION BONE SCREW 6.5MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HWC·September 19, 2014

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012