BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    T/K (ATA/AMA) UNIVERSAL BIOPAK

    FDA 510(k)
    FDA Class 2 ·Immunology

    EasyTouch

    FDA UDI
    MHC MEDICAL PRODUCTS, LLC·MHC18023081·

    OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A

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

    MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

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    FDA Adverse Event
    Malfunction ·SYNTHES (USA) LLC·Product code HTW·April 28, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 23, 2012

    UNKNOWN DEPUY METAL LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·August 10, 2010

    GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017