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

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    ABNORMAL HEMOGLOBIN CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OPTISENSE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·May 9, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·October 19, 2012

    VERSACARE

    FDA Adverse Event
    Injury ·HILL-ROM, INC.·Product code FNL·August 10, 2010

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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