BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    Next Generation iBOT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Pathfinder

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522125645·PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG)

    Pathfinder

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522124563·PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG)

    OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Neurology

    ORTHOFLEX ROD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMISTEM H HA COATED STD STEM SIZE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 8, 2018

    PROSIMA PELVIC FLOOR REPAIR KIT

    FDA Adverse Event
    Injury ·ETHICON INC·Product code OTP·June 17, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 20, 2011

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·September 19, 2008

    2.5MM DRILL BIT/QC/GOLD/110MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTW·February 4, 2014

    PRESSURE MONITORING KIT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·July 9, 2021

    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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021