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

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    PERFRINGENS AGAR BASE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Klassic HD® Hip System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MagiCath II

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 23, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    LIFEVEST WCD 3100 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 6, 2010

    LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 56 MM O.D. SHELL

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·March 15, 2022

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·March 15, 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