BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    THE LUNG GYM (XLATOR AND NLATOR)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PHOTOMETER LP 1

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·February 28, 2022

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 26, 2022

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·August 22, 2022

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·November 28, 2023

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·April 18, 2023

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·September 25, 2024

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 15, 2025

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 1, 2024

    SPRINT QUATTRO SECURE

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

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 7, 2012

    REFLEX-HYBRID 1 LEVEL ACP SIZE 18MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-FRANCE·Product code KWQ·June 23, 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