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

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    Lung-CAD

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO VIABAHN ENDOPROSTHESIS

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

    STITCHKIT

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

    BD SYRINGE 3ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 22, 2023

    VERITY ADX SR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 26, 2011

    TOTALCARE BARIATRIC PLUS BED

    FDA Adverse Event
    Other ·HILL-ROM, INC.·Product code FNL·July 2, 2013

    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026