BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365116865·

    FINE JECT INSULIN PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ISOFLEX LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DTB·January 11, 2014

    4000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 18, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·August 4, 2011

    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