BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    Ceramic Bracket

    FDA 510(k)
    FDA Class 2 ·Dental

    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    MODIFICATION TO SYNTHES MATRIX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    15-INCH (38 CM) COLOR LCD MONITOR CDL1576A

    FDA 510(k)
    FDA Class 2 ·Radiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 17, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 20, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·July 22, 2011

    MODIFIED NOVY CORNUAL CANNULATION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MOV·March 14, 2024

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·January 18, 2016

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 7, 2013

    MODIFIED NOVY CORNUAL CANNULATION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MOV·January 10, 2024

    MODIFIED NOVY CORNUAL CANNULATION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MOV·November 22, 2024

    5.5MM TI CURVED ROD 45MM

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·February 6, 2020

    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