BEUDAMED
    9 results · 19ms · 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 ×

    FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    STEALTH DILATION CATHETER SYSTEM/MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    URIC ACID TEST ITEM NUMBER 65422

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MINI QA+ #0 ETH OS-2 *EA

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code HWC·May 9, 2018

    QC Ø1-4 F/TRS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·March 8, 2013

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·July 23, 2014

    UROLOGICAL QUAD LEAD

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code EZW·January 14, 2011

    LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Recall
    Terminated ·Zest Anchors LLC·Product code DZE·January 16, 2014

    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Enforcement
    Class II ·Terminated·Zest Anchors LLC·February 12, 2014