BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    PINK CAD/CAM disc

    FDA 510(k)
    FDA Class 2 ·Dental

    FORMATK MAGMA PLATFORM LASER

    FDA Adverse Event
    Injury ·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019

    SONICATOR 740, MODEL ME 740

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AYCAN WORKSTATION OSIRIX PRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    FORMATK MAGMA PLATFORM

    FDA Adverse Event
    Malfunction ·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 8, 2013

    9600

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

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024