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

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    BAYER PSA ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ROSCO PYRR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    AT HOME DRUG TEST PHARATECH

    FDA Adverse Event
    PHAMATECH·Product code MVO·September 24, 2003

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 13, 2013

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 17, 2011

    CAPSURE Z NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·August 8, 2014

    Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

    FDA Enforcement
    Class I ·Ongoing·American Contract Systems, Inc.·July 13, 2022