BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    SiteRite™ 9 Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Compressible Limb and Circulation Therapy System, Model POWER-Q2300

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MYSPINE UNILATERAL LEFT GUIDE S01

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024

    PROPHECY INFINITY

    FDA Adverse Event
    Malfunction ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HSN·March 29, 2021

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

    FORCE FX-C GENERATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·July 25, 2011

    VELA DIAMOND

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·July 11, 2013

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 8, 2024

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    FDA Adverse Event
    Malfunction ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 19, 2023

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    FDA Adverse Event
    Malfunction ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·May 28, 2024

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    FDA Adverse Event
    Malfunction ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·July 15, 2025

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    FDA Adverse Event
    Malfunction ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·December 2, 2022

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    FDA Adverse Event
    Malfunction ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 22, 2024

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 11, 2024

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    FDA Adverse Event
    Malfunction ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·May 2, 2025

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    FDA Adverse Event
    Malfunction ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·April 29, 2025

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    FDA Adverse Event
    Malfunction ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·December 18, 2023

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014