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

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    Sofia Strep A+ FIA, Sofia 2 Analyzer

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CHLORAPREP ONE STEP HI-LITE ORANGE

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code KXG·December 28, 2020

    INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES

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

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Injury ·B.BRAUN SURGICAL SA·Product code MPN·July 23, 2019

    VITEK® 2 AST-ST01 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·October 24, 2017

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 10, 2013

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 15, 2011

    APEX DOVETAIL TIBIAL TRAY

    FDA Adverse Event
    Malfunction ·OMNI LIFE SCIENCE INC·Product code HSH·September 18, 2008

    Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·January 7, 2015

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021