BEUDAMED
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    EQUATION FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00887661636041·

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00196365849429·

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00196365848927·

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00193033574881·

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00193033574850·

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00193033574898·

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00196365849368·

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00196365849061·

    UNIVERSAL THREAD

    FDA UDI
    FGX INTERNATIONAL INC.·00193033574904·

    MINIMED MIO ADVANCE

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·October 10, 2025

    INSET GUARD

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·November 5, 2025

    ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EMIT II PLUS METHADONE ASSAY, MODEL OSRE229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·March 1, 2016

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·November 15, 2015

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 21, 2013

    ACTIVE FIXATION ENDOCARDIAL LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE SJ·Product code JPA·March 14, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012