BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BD AUTOSHIELD PEN NEEDLE

    FDA Adverse Event
    Injury ·BD MEDICAL - INFUSION THERAPY SYSTEMS·Product code FMI·October 27, 2011

    Revolution Ascend

    FDA 510(k)
    FDA Class 2 ·Radiology

    MyGlucoHealth Wireless System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LINER: MPACT 01.26.2856MHC DOUBLE MOBILITY HC LINER 28/DMH

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·January 10, 2024

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·November 7, 2008

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 31, 2011

    CARESTREAM DRX-EVOLUTION FULL FEATURED WALL ST

    FDA Adverse Event
    Malfunction ·CARESTREAM HEALTH, INC.·Product code KPR·July 18, 2013

    ALINITY I RUBELLA IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 26, 2025

    ALINITY I RUBELLA IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 7, 2025

    ALINITY I RUBELLA IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·February 13, 2026

    Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·January 16, 2013