BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    BACILLUM PUMILUS SPORE STRIPS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517367341·CoRoent® LN, 10x9x30mm

    RGX 3 PEG SER A PATELLA 34MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HRY·December 23, 2019

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00812171023500·INTERFERENCE SCISSORSEW, PEEK, 9.0MMX30MM, STER

    LIFT VB SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTIVE WASTE GAS SCAVENGER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HEARTSTART FRX

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

    ENRHYTHM

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·October 31, 2012

    LIFEVEST WCD 3100 SYSTEM

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

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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