BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    Daye Tampon

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NanoZoomer S360MD Slide scanner system

    FDA 510(k)
    FDA Class 2 ·Pathology

    IDENTITY DR

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

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·August 18, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·July 2, 2013

    NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)

    FDA Adverse Event
    Malfunction ·HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,·Product code PSY·June 5, 2023

    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