BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    REAL FIBER OPTIC URETERAL TRANSILLUMIN

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

    LYMPHANGIOGRAPHY SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHOFIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·May 28, 2014

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 15, 2012

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 9, 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