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

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    Dynamic Coronary Roadmap 2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUANTITATIVE NEUROQ 3.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS

    FDA 510(k)
    FDA Class 2 ·Dental

    GMK-HINGE FEMORAL COMPONENT SIZE 3 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·July 25, 2022

    ESOPHYX Z

    FDA Adverse Event
    Injury ·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 17, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code MMI·July 22, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 18, 2008

    SUREFORM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code GDW·January 17, 2024

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014