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

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    Filters Regulation: Us FDA ×

    Ceramill Zolid FX

    FDA 510(k)
    FDA Class 2 ·Dental

    INNOCURE IMRT FILTER (COMPENSATORS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICRODOT & MICRODOT XTRA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code DTB·June 7, 2013

    LANX POSTERIOR CERVICOTHORACIC FIXATION SYSTEM

    FDA Adverse Event
    Malfunction ·LANX, INC.·Product code KWP·June 22, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    BD MAX¿ EXT ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·March 5, 2026

    BD MAX¿ EXT ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·March 9, 2026

    BD MAX¿ EXT ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·March 9, 2026

    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