BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    ECHELON Oval V 5.1 MRI System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111091506·SKLCT COTTLE DORS SCIS ANG61/2

    SMARTPILL GI MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    QUADRA ASSURA DR CRT-D

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

    CAPSUREFIX

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

    9800

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

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code HAW·October 8, 2021

    SYRINGE 3ML SALINE FILL CHINA SP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code NGT·February 22, 2024

    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