BEUDAMED
    10 results · 22ms · Sources: EU EUDAMED, US FDA

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    Orthex External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ryno Lacer Wrist and Thumb Support

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357237869·

    DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    RIATA ST PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    TECNIS 1-PIECE

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·August 25, 2011

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 10, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026

    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