BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    INDXTM DIP-S-TICKSTM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GEMORE TENS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    IVAC #1160 MULTIPLE VITAL SIGNS UNIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·January 17, 2013

    EQUASHIELD

    FDA Adverse Event
    EQUASHIELD·Product code FPA·November 17, 2010

    CONFIRM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·July 8, 2014

    Philips Azurion system; Software Version Number: R3.1;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 28, 2026

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021