BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M3848134880·Triangle Plate - Ø1.5 mm - 3 hole - 16 mm

    SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8

    FDA 510(k)
    FDA Class 2 ·Neurology

    JAZZY ELITE 6

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·May 15, 2014

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 2, 2015

    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