BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    HUMAN CHORIONIC GONADOTROPIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970396·anteriors; shade D2; mould UCL

    MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAGNETOM Vida

    FDA 510(k)
    FDA Class 2 ·Radiology

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·February 20, 2013

    WIRE COLLET

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·January 18, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 31, 2014

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

    BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020

    BD TRUCOUNT¿ TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025