BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    TM-3600 A NEURODIAGNOSTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Stainless Steel Wire

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746050053·WIRE SS POSTED UNIV 019 X 025 30MM 10/PK

    IG4 IMAGE GUIDED SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    STERRAD 100NX Sterilizer with ALLClearTM Technology

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·June 10, 2014

    LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·October 7, 2010

    CAPSTONE® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code MAX·December 6, 2012

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012