BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    COLLIMATOR MODEL A280BLE & MODEL A280-BLM

    FDA 510(k)
    FDA Class 2 ·Radiology

    JOBST Maternity

    FDA UDI
    BSN MEDICAL, INC.·04042809643596·OPAQUE MATERNITY 15-20 MM HG WAIST HIGH ZIG ZAG...

    TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSUREFIX NOVUS

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

    SM, LT ULNA COMPONENT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDC·October 5, 2010

    IN TOUCH ZU

    FDA Adverse Event
    Malfunction ·FLEXTRONICS EMS CANADA·Product code FNL·October 31, 2012

    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