BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    BBL ANAGEL POWDER

    FDA 510(k)
    FDA Class 1 ·Microbiology

    QUANTUM WARP 10 LIGHT DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OMNI PATENT MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GEMSTR 7 THPY ALT ST

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 7, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 14, 2012

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 13, 2010

    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