BEUDAMED
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    AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MODEL STT-100

    FDA 510(k)
    FDA Class 2 ·Radiology

    ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    EON IPG

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·December 9, 2010

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Injury ·ALCON- IRVINE TECHNOLOGY CENTER·Product code HQC·January 17, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 5, 2014

    Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class I ·Terminated·Covidien·February 11, 2015