BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Hospira Extension Sets

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MH1 MICROHOLTER RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DUROM ACETABULAR COMPONENT 54/48 CODE N

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·October 6, 2014

    BROOKER TIBIAL INTERLOCKING NAIL 10MM X 35CM

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code HSB·July 7, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 7, 2013

    MEMORY II DOUBLE LUMEN EXTRACTION BASKET

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code LQR·July 28, 2021

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019