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

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    Volpara Imaging Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111071744·SKLHN MAYO SCISS CVD SERR 6.75

    Prime Medical LLC

    FDA UDI
    Prime Medical LLC·00850055249295·PrimePadPlus-K15-3422

    MOBILEECG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FRESH, DENTAL IMPRESSION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·October 8, 2014

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWP·June 8, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; 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