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

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    FRC POSTEC PLUS

    FDA 510(k)
    FDA Class 1 ·Dental

    SPO2 WRAP SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WINNER CM4 COMBINATION UNIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    WECK VISISTAT 35W 6/BOX

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GDT·April 4, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·March 30, 2011

    VITALITY DS

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    TI LOW PROFILE SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 20, 2019

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013