BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    THE WELLCOME ROTAVIRUS LATEX TEST ZL40

    FDA 510(k)
    FDA Class 1 ·Microbiology

    IPS CaseDesigner

    FDA 510(k)
    FDA Class 2 ·Radiology

    Disposable Blood Lancet (Soft)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ADAPTA DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·June 10, 2014

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·November 29, 2012

    FLEXI-SEAL SIGNAL FMS

    FDA Adverse Event
    Malfunction ·CONVATEC, INC·Product code KNT·June 22, 2015

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

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

    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