BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    RxSight Insertion Device

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    IQMARK DIGITAL HOLTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAPCHECK2, ARCCHECK

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

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

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·July 17, 2013

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·November 3, 2025

    TRUENESS

    FDA Adverse Event
    Injury ·SINOCARE INC·Product code NBW·October 15, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC.·Product code NBW·November 28, 2025

    TRUENESS

    FDA Adverse Event
    Injury ·SINOCARE INC ADDRESS LINE 1 NO.265 GUYUAN·Product code NBW·October 20, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·May 29, 2026

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·March 11, 2026

    TRUENESS AIR

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·February 26, 2026

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·October 20, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·November 19, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC.·Product code NBW·October 10, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·April 28, 2026

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·February 9, 2026

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·February 25, 2026

    Revogene, Catalog no. 610210. IVD test instrument

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