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

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    Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PSX INTERBODY SYSTEM

    FDA Adverse Event
    Injury ·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025

    MYSPINE UNILATERAL LEFT GUIDE S01

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

    ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ACUMED SMALL BONE LOCKING ROD SYSTEM II

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·June 18, 2025

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 6, 2014

    HEART START XL

    FDA Adverse Event
    Death ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 25, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·July 17, 2013

    Revogene, Catalog no. 610210. IVD test instrument

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