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

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    Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·September 14, 2016

    FASTTAKE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 18, 2005

    ZIOSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    FRONTIER DEVICES NEURO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·August 22, 2018

    ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2020

    ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 14, 2013

    CENTRICITY

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code LLZ·July 18, 2011

    TERUMO PERFUSION SYSTEM 9000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·September 11, 2008

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·January 23, 2019