BEUDAMED
    10 results · 29ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Action Trackstander models TR1816, TR1820, TR2016, and TR2020

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BIO-CLAD ALL POLY CUP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304255777·

    NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ROD, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

    V.A.C. GRANUFOAM DRESSING

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 15, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·June 11, 2013

    UNKNOWN PRODUCT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·September 10, 2008

    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