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

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    21HQ513D

    FDA 510(k)
    FDA Class 2 ·Radiology

    SWIFT FX NANO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    O.B. TAMPONS

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

    CERTAIN GOLD-TITE HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·March 1, 2021

    NEXTAR SPINE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

    RIATA ACTIVE FIXATION LEAD

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

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

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

    0001825034-2013-02664

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBV·July 12, 2013

    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