BEUDAMED
    7 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.

    RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Thommen Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    NUVASIVE COROENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 13, 2014

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code JJE·October 16, 2010

    ASR ACETABULAR CUPS 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 13, 2012

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022