BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    PacEndo Sodium Hyprochlorite

    FDA 510(k)
    FDA Unclassified ·Unknown

    Orthopedic Salvage System (OSS)

    FDA UDI
    Biomet Orthopedics, LLC·00880304674479·

    CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SINGLE AMPLIFIER FOR BOTOX

    FDA 510(k)
    FDA Class 2 ·Neurology

    RESOLUTION 360 CLIP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·December 2, 2024

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·June 20, 2017

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·August 1, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·July 25, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·August 17, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·March 21, 2017

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    CONSMA·Product code ITJ·October 8, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code DXY·June 7, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 6, 2011

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·June 26, 2017

    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

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 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