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

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    Medone Ultra, Medextra

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

    PureLife+ CSR Wrap

    FDA UDI
    PURELIFE, LLC·D79011921011·PureLife+ CSR Wrap , 12" x 12" , Provides barri...

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583032511·ET40, KIT 312 NFM 85 L BE ENCHANT 40

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071921010C0·21.5" cust charnley cur.str. 9"handle

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180543740·Threaded Graft Tube

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071921011C0·21.5"cust.charnley cur.ang. 9"handle

    SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA

    FDA 510(k)
    FDA Class 1 ·Neurology

    REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OMNIFIX®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·October 7, 2008

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    NONIN

    FDA Adverse Event
    Other ·CAREFUSION 211, INC.·Product code DQA·December 13, 2010

    VALIANT STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·August 4, 2017

    TALENT AAA STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 4, 2017

    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

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    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