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

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    HS30 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER

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

    GUAVA II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POLYMOBIL PLUS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHINEERS AG·Product code IZL·February 24, 2026

    SMARTSITE NEEDLE-FREE VALVE

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·October 19, 2016

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 26, 2022

    COBAS 6000 CORE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·June 21, 2013

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIM·July 28, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    MOBILETT ELARA MAX

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE GMBH·Product code IZL·December 18, 2020

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 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 Inc.·July 11, 2018

    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