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

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    Icobrain

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583032801·ET20, KIT 312 2.4G NFM 75 R BE ENCHANT 20

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780419136·Integra® Miltex® Wullstein Ear Forceps 3-1/8" S...

    EXPERIENCE®

    FDA UDI
    Gc Orthodontics America Inc.·D78819213000201·EXMRC MBT 022/UR3 - 7T 8A

    EXPERIENCE®

    FDA UDI
    Gc Orthodontics America Inc.·D78819213000101·EXMRC Roth 022/UR3 - 2T 13A 4M

    DUETTO MT

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·April 14, 2022

    RASCAL WE GO 250 POWERED WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TENZING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ZERO-P VA IMPLANT 6MM HEIGHT LORDOTIC-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·June 27, 2013

    SEE H-10

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·August 4, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·October 7, 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