BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    Avologi ENEO

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

    RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRA-SOFT SV BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·July 7, 2006

    RAINBOW R1 25L SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·June 19, 2015

    ECHELON 45 ENDOPATH STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 27, 2011

    WALLSTENT? BILIARY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·June 21, 2013

    ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GCJ·September 30, 2008

    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