BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    AS165 RESPIRATION MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    JOBST Maternity

    FDA UDI
    BSN MEDICAL, INC.·04042809642018·OPAQUE MATERNITY 15-20 MM HG THIGH HIGH ZIG ZAG...

    Etgar Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 28, 2014

    EPIX UNIVERSAL CLIP APPLIER

    FDA Adverse Event
    APPLIED MEDICAL·Product code FZP·November 26, 2012

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·June 19, 2015

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; 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