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

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    GASTROINTESTINAL DILATOR

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

    Disposable Anesthesia Circuits

    FDA UDI
    WESTMED, INC.·00709078010446·Anesthesia Circuit, Adult, 60", GSE w/CAP, Para...

    STRYKER WEDGE SUTURE ANCHOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THE MAGTEC SYSTEM

    FDA 510(k)

    MAGNUM TRISPIKE CUP 60ODX54ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 30, 2014

    SILTEX SALINE-FILLED MAMMARY PROSTHESIS

    FDA Adverse Event
    Injury ·MENTOR TEXAS, INC.·Product code FWM·August 2, 2012

    LOGICAL DOUBLE KIT

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL LTD.·Product code DRS·September 16, 2010

    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·September 21, 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