BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    BIOSTREP A-DIRECT STREP A ANTIGEN TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TIBIAL NAIL, STANDARD 10X390 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·March 17, 2010

    ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CHLORIDE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD VACUTAINER® SINGLE USE HOLDER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·December 6, 2017

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·February 28, 2013

    ISYMM INTRAOCULAR LENS

    FDA Adverse Event
    Malfunction ·HOYA SURGICAL OPTICS, INC.·Product code HQL·July 7, 2014

    INFUSION ADMINISTRATION SET WITH 1.2MIC FILTER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·February 10, 2011

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021