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

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    Coldplay CryoBalloon® Ablation System

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

    CLEARSTART SVM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNGO.CT NEURO PERFUSION

    FDA 510(k)
    FDA Class 2 ·Radiology

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·July 17, 2015

    FORTIFY ASSURA VR, DF-4 CONNECTOR

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

    CAPSURE FIX

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

    LAPAROSCOPIC ABC PROBE

    FDA Adverse Event
    Malfunction ·CONMED CORP.·Product code GEI·July 2, 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