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

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    TEA Device

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707023180·CALIBRA BANDS 2ND MOLAR n.SUL 26

    C Scope Visualization System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PEDIGUARD NERVE DETECTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    HEART LUNG MACHINE

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code KFM·February 21, 2025

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·November 12, 2008

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·August 12, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 16, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020