BEUDAMED
    10 results · 22ms · Sources: EU EUDAMED, US FDA

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    SYVA ADVANCE CORTISOL ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INION FREEDOMPIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Alinity i Toxo IgM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·April 22, 2026

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 27, 2014

    ACCU-CHEK SPIRIT CARTRIDGE

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEM INC.·Product code LZG·November 9, 2012

    UNK DY

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FJS·September 2, 2010

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·June 2, 2025

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·September 11, 2025

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015