BEUDAMED
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    ALARIS PC UNIT, MODELS 8000 AND 8015

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065821·EXTRAORAL ELASTICS 1/4" 8 oz

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450401484·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450439623·

    MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MULTISTIM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 12, 2023

    WAVEWRITER ALPHA? PRIME 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 11, 2025

    PASSPORT 2 MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code DSI·April 30, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

    X8000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·May 4, 2011

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    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