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

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    LASER SKIN MARKER AND MASK WHITE LOTION

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    JOBST Maternity

    FDA UDI
    BSN MEDICAL, INC.·04042809642230·OPAQUE MATERNITY 15-20 MM HG THIGH HIGH ZIG ZAG...

    FFRct

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRIACTIV FX EMBOLIC PROTECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SENSIA DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NVZ·October 8, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014

    BB (BIGBORE) ONCOLOGY CT

    FDA Adverse Event
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·November 29, 2012

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; 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