BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Terrace™ Anterior Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FOX MEDICAL DIODE LASER SYSTEM 810NM

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

    UNKNOWN DEPUY BONE CEMENT

    FDA Adverse Event
    Injury ·9610921 DEPUY CMW·Product code LOD·February 15, 2013

    STERLING?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·July 29, 2014

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·January 18, 2011

    TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views

    FDA Recall
    Terminated ·Infraredx, Inc.·Product code OGZ·December 15, 2016

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026