BEUDAMED
    7 results · 29ms · Sources: EU EUDAMED, US FDA

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    PowerPICC Provena Catheters

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INTRAFIX TIBIAL SHEATH

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FLEXCATH STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·July 14, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 11, 2013

    X-STOP IPD SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SPINE LLC·Product code NQO·September 16, 2008

    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