BEUDAMED
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    Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FlareHawk TiHawk9 Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DUOPATH VEROTOXINS GLISA TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CERTAIN® STRAIGHT HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H)

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·January 30, 2020

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE PTE.LTD·Product code FRN·November 17, 2008

    GYNNIE OB-GYN STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code HDD·July 18, 2011

    MCP SZ. 30 PROXIMAL WW

    FDA Adverse Event
    Injury ·ASCENSION ORTHOPEDICS·Product code NEG·July 15, 2013

    BD SLIP TIP SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·May 12, 2022

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025