BEUDAMED
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    'RAPIDONE'-METHADONE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040017340·Zirlux 16+ D98,5*30 (step) A2

    I-PORT ADVANCE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 15, 2025

    K012364

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 3, 2015

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033358924·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033358894·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033358931·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033358870·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033358917·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033358900·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033358887·

    PicoSure 1064 Delivery System

    FDA UDI
    Cynosure, LLC·00841494106997·PicoSure 1064 Delivery System

    MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ICG MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 13, 2013

    HEMOCHRON RESPONSE COAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code JPA·February 1, 2011

    MULTI-LINK 8

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MAF·December 29, 2020

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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