BEUDAMED
    7 results · 16ms · Sources: EU EUDAMED, US FDA

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    DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FLOW-PAC CHLORIDE REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPIROMETRICS 2451 & SMI I

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ELECTRIC PEN DRIVE 60,000 RPM

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code HWE·June 10, 2014

    ITREL 3

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·October 7, 2010

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 10, 2012

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024