BEUDAMED
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    SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    Helios+ UV-C System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IMPL TWIST MP-1 3.75 MM 8 MM

    FDA Adverse Event
    Malfunction ·ZIMVIE US CORP LLC·Product code DZE·April 29, 2026

    ADVANTAGE SERIES 26 OBS 10/04

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·February 4, 2013

    HARMONIC CURVED SHEARS INSERT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·December 30, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 17, 2014

    IMPL TWIST MP-1 3.75 MM 8 MM

    FDA Adverse Event
    Injury ·ZIMVIE US CORP LLC·Product code DZE·May 1, 2026

    IMPL TWIST MTX 3.75 MM 10 MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 26, 2024

    IMPL TWIST MTX 3.75 MM 15 MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·December 14, 2022

    IMPL TWIST MTX 3.75 MM 13 MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 4, 2021

    IMPL TWIST MTX 3.75 MM 13 MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 4, 2021

    IMPL TWIST MP-1 3.75 MM 1 3 MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·April 7, 2022

    IMPL TWIST MP-1 3.75 MM 1 0 MM

    FDA Adverse Event
    Injury ·ZIMVIE US CORP LLC·Product code DZE·December 20, 2025

    IMPL TWIST MP-1 3.75 MM 1 0 MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·June 19, 2020

    IMPL TWIST MTX 3.75 MM 13 MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 26, 2024

    IMPL TWIST MP-1 3.75 MM 8 MM

    FDA Adverse Event
    Injury ·ZIMVIE US CORP LLC·Product code DZE·May 5, 2026

    IMPL TWIST MTX 3.75 MM 13 MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 4, 2021

    IMPL TWIST MP-1 3.75 MM 8 MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 9, 2022