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

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    KeraStat Cream

    FDA 510(k)
    FDA Unclassified ·Unknown

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10888277902220·IV START KIT

    EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

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

    R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    56MM AND R3 ACETABULAR SHELL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

    SET, ADMINISTRATION

    FDA Adverse Event
    Injury ·CARDINAL HEALTH ALARIS PRODUCTS·Product code FPA·October 6, 2008

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 4, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 27, 2013

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012