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

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    1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Orthodontic Silicone Wax

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746147371·SUPPLIES-ORTHODONTIC SILICONE WAX 50/PKG

    DYNATECH JD7/JD7P COLPOSCOPE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR

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

    ATTAIN OTW

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

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 4, 2010

    TRITANIUM ACETABULAR TRIAL 54MM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOAPEDICS MAHWAH·Product code LXH·November 2, 2012

    RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant

    FDA Recall
    Terminated ·BioHorizons Implant Systems Inc·Product code DZE·October 30, 2015

    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