BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    NEXXIS OR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    METER C - OT ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·February 7, 2002

    PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LO-50 LED LIGHT SOURCE

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

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 21, 2013

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 13, 2011

    CARTO XP EP NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·August 14, 2008

    SOMATOM Edge Plus-Computed tomography system Model 1026700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025