BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    JOBST Maternity

    FDA UDI
    BSN MEDICAL, INC.·04042809640151·OPAQUE MATERNITY 15-20 MM HG KNEE HIGH ZIG ZAG ...

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981130428·Trial 20x15x12mm, 10 Deg Lordosis, w/ Depth Stop

    DOPPLER ULTRASONIC STETHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Radiology

    TELETRACE TELEPHONE EKG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVEAL DX

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DSI·October 8, 2010

    NEXGEN CR ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·November 28, 2012

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    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