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

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    Actera™ hip system

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205003904·Luna Opal MB Mini .022 UR2 (+10°T +8°A)

    AsoAligner

    FDA 510(k)
    FDA Class 2 ·Dental

    AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BD VACUTAINER® VENOUS BLOOD COLLECTION TUBE SERUM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JKA·October 5, 2023

    BAB FLEXIBLE FABRIC BANDAGES

    FDA Adverse Event
    Injury ·KENVUE BRANDS, LLC·Product code KGX·April 1, 2025

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·October 26, 2017

    KINAIRE MED SURG

    FDA Adverse Event
    KINETIC CONCEPTS, INC.·Product code INX·October 15, 2008

    TECNIS MULTIFOCAL

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code MFK·August 23, 2011

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·July 11, 2013

    Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack

    FDA Enforcement
    Class I ·Ongoing·Cardinal Health 200, LLC·November 1, 2023

    BD CONVENTIONAL NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·December 26, 2024

    BD CONVENTIONAL NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·December 26, 2024

    BD CONVENTIONAL NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·December 26, 2024

    Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T

    FDA Enforcement
    Class I ·Ongoing·Cardinal Health 200, LLC·February 14, 2024

    Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025