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

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    Alphatec Navigation Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383507752·Gutta Percha Points is used to root canal filin...

    C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·Immunology

    ZEUS ELISA HSV GG-2 IGG TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 28, 2024

    COMMUNICATOR

    FDA Adverse Event
    Malfunction ·EXTERNAL MANUFACTURER·Product code LWS·July 7, 2011

    CAPSUREFIX MRI SURESCAN

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

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 11, 2008

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; 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