BEUDAMED
    10 results · 22ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO SPACE CPSXL BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODEL 4815 ADAPTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARBON POST

    FDA 510(k)
    FDA Class 1 ·Dental

    PALMAZ GENESIS AMIIA

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code FGE·April 23, 2013

    COROX OTW-S 85-BP

    FDA Adverse Event
    Death ·BIOTRONIK SE & CO. KG·Product code NVZ·April 22, 2011

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008

    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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022