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

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020

    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 2089507-140; g)¿¿¿¿¿ 2089507-144; h)¿¿¿¿ 2089507-145; i)¿¿¿¿¿¿ 2089507-149; j)¿¿¿¿¿¿ 2089507-153; k)¿¿¿¿¿ 2089507-154; l)¿¿¿¿¿¿ 2089507-155; m)¿¿¿ 2089507-156; n)¿¿¿¿ 2089507-157; o)¿¿¿¿ K2037DAED; p)¿¿¿¿ K2037DBED; q)¿¿¿¿ K2037DED; r)¿¿¿¿¿ K2037DJED; s)¿¿¿¿¿ K2037DNED; t)¿¿¿¿¿ K2042TTED; u)¿¿¿¿ K2049DC; v)¿¿¿¿¿ K2049DD; w)¿¿¿ K2049DF; x)¿¿¿¿¿ P2037DAED; y)¿¿¿¿¿ P2037DBED; z)¿¿¿¿¿ P2037DED; aa)¿¿ To be provided

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·October 16, 2024

    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 TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. 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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023