BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    Aptima Combo 2 Assay (Panther System)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515023512·Volkman Retractor, USA, 3 prong, sharp, 8 3/4"

    ADVIA CHEMISTRY GLUH_3 REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KOWA GENESIS-D

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 15, 2014

    SCRDRIVER-CRUCIF NOT SELF-HOLDING F/CORT

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HXX·June 20, 2013

    OCTRODE LEAD, 30CM LENGTH

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·May 5, 2011

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020