BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000

    FDA 510(k)
    FDA Class 2 ·Neurology

    NANOKNIFE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code KWQ·September 27, 2016

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·June 7, 2013

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011

    VERSACARE

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

    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