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

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    MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169595590·TRIAL 2192355 O25 IB 27MM 12 DEG 12X55

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111116·KATENA INSTRUMENT RACK

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 2, 2025

    MONOLISA ANTI-HAV EIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ZIP'R MANTIS POWERED WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    KANGAROO

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·October 16, 2024

    COPIOS PERICARDIUM MEMBRANE

    FDA Adverse Event
    Injury ·Product code NPL·June 10, 2020

    QUICKFLEX MICRO LV LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code NIK·January 11, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR·Product code MVK·June 18, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 4, 2011

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016