BEUDAMED
    14 results · 30ms · Sources: EU EUDAMED, US FDA

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    Affinity Fusion™ Oxygenator System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925018273·OLYMPUS LIGHT SRC ADAPTOR

    Lumipulse G CA 15-3 Calibrators

    FDA UDI
    FUJIREBIO INC.·04987270230640·

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIEMENS MICRO2+ WITH VAI SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 10, 2024

    BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·September 19, 2022

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 6, 2008

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Injury ·OGDEN MANUFACTURING·Product code FJI·August 12, 2011

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·July 16, 2013

    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·March 4, 2020

    UNSPECIFIED BD¿ INTIMA-II

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·July 14, 2023

    CODMAN Disposable Perforator 11mm. Cranial Perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025

    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