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

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    NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MEDTRONIC M2 MAGNET ADJUSTMENT TOOL

    FDA 510(k)
    FDA Class 2 ·Neurology

    EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    CONCERTO

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

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·June 24, 2011

    GE OEC FLUOROSTAR 7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 10, 2008

    C-QUR MOSAIC

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORPORATION·Product code FTL·October 9, 2015

    LIGASURE

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·March 21, 2022

    Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573, Ultrasound Biopsy Pack -Rx/AMS6828, Ultrasound Biopsy Pack -Rx/AMS6828A, C Access Tray/AMS9954, C Access Tray/AMS9954A, Access Tray A/AMS10234, Access Tray A/AMS10234A, C-Access Tray Chicago/AMS10236, C-Access Tray Chicago/AMS10236A, Access Tray/AMS10238, Access Tray/AMS10238A, Access Tray/AMS10238B, Gray Pack/AMS10247, Gray Pack/AMS10247A, C-Access Tray/AMS10249, C-Access Tray/AMS10249A, C Access Tray/AMS10255, C Access Tray/AMS10255A, Jacksonville Tray/AMS10256, Jacksonville Tray/AMS10256A, Jacksonville Tray/AMS10256B, NVS Access Tray/AMS10257, AZ Access Tray/AMS10271, AZ Access Tray/AMS10271A, Fistulagram/ C-Access Pack/AMS10280, Fistulagram/ C-Access Pack/AMS10280A, Ultrasound Tray w/PDI/AMS10710A, Procedure Tray/AMS10897A, Universal Block Tray-RX/AMS12381, Ultrasound Injection-RX/AMS12382, Pellet Insertion Tray/AMS12735, PICC Insertion Tray - RX/AMS-7192CS-8, Breast Biopsy Tray/DDS1010G, Single Shot Epidural Tray-Rx/DDS1149, PICC Insertion Tray-RX/VYMAXBASIC

    FDA Enforcement
    Class II ·Ongoing·Windstone Medical Packaging, Inc.·May 25, 2022

    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