BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    MICROFUSE BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONMED

    FDA UDI
    Conmed Corporation·10845854002056·OSCILLATOR BLADE, 19.5 X 71 X 0.8 MM (.031")

    SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEARTSTART MRX, MODEL M3535A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HSB·April 22, 2013

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 10, 2008

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 27, 2011

    IRIDEX IQ577 LASER SYSTEM

    FDA Adverse Event
    Injury ·IRIDEX CORP.·Product code GEX·November 4, 2013

    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