BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    HardyDisk AST Omadacycline 30µg (OMC30)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACAM 5 AUDIOMETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 17, 2014

    MAXIMO II CRT-D

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NIK·July 28, 2011

    BONE SCREW, T7, DIAM. 2.7X16MM

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG·Product code HRS·October 28, 2015

    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