BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    O.R. DATA MANAGER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SCANLAN® John Ross Tunneler System

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159035735·SCANLAN® John Ross Tunneler System, 9mm Sheaths

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 21, 2022

    IVC TWO MEDIUM

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

    E-STATIS 40 SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 27, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIVISION·Product code FNL·November 10, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 13, 2012

    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 1, 2014