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

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    LIQUID LDH-L REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Prizma

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·September 9, 2024

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    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS INC.·Product code LJS·February 15, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·January 19, 2011

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 1, 2014

    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