BEUDAMED
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    ERIS LAYERING MATERIALS

    FDA 510(k)
    FDA Class 2 ·Dental

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040018927·Zirlux 16+ D98,5*30 (step) C3

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450241332·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033359525·

    TRAY ADAPTERS, MULTIPLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 8, 2025

    ECAREMANAGER V3.6

    FDA Adverse Event
    Malfunction ·VISICU·Product code MSX·September 21, 2009

    ECAREMANAGER V3.6

    FDA Adverse Event
    Malfunction ·VISICU·Product code MSX·December 14, 2009

    FREESTYLE FLASH

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

    OCTRODE

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

    75MM SELECTABLE NEW TLC

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 9, 2011

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·July 31, 2013

    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

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024