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

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    VersiHD with GuideMe software

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STERISPINE PS PEDICLE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PD CASTA-H

    FDA 510(k)
    FDA Class 2 ·Dental

    I-STAT

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code CHL·April 21, 2023

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·November 6, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 1, 2011

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 16, 2013

    CODMAN Disposable Perforator 11mm. Cranial Perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025

    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