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

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    Vivio® LVEDP System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Motion Manager Wrist Support

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357239054·

    ATHENA PELVIC MUSCLE TRAINER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    QUICKSITE LV

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

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Injury ·ALCON RESERACH, LTD./HUNTINGTON·Product code HQL·August 18, 2011

    SPECTRUM INFUSION PUMP

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