BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    INNOVANCE D-DIMER, MODEL OPBP09

    FDA 510(k)
    FDA Class 2 ·Hematology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450329962·

    SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2024

    CLINITEK STATUS+

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JHI·December 2, 2019

    ELLIPSE DR, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014

    AMPHIRION DEEP

    FDA Adverse Event
    Injury ·INVATEC SPA·Product code DQY·May 3, 2013

    FLEXTEND

    FDA Adverse Event
    Death ·CPI - DEL CARIBE·Product code NVN·May 17, 2011

    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