BEUDAMED
    329 results · 24ms · Sources: EU EUDAMED, US FDA

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    3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694019835·FPS 2.0mm x 22mm Standard Screw

    MEGA5.5 SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809228125777·Rod, Ø5.5 x 220mm

    Thino Roth Bracket, .022, Mini Size, UR2

    FDA UDI
    Astar Orthodontics Inc.·06941673501552·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120220·Assembly, Screwdriver, Extended Tab

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694073844·FPS 2.0 x 22mm Screw Sterile Qty 5

    JDEVOLUTION S

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·August 6, 2025

    ATHEROEDGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·September 4, 2024

    BD¿ ECCENTRIC LUER SLIP TIP SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·August 30, 2023

    EDP 20/B

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code DTB·October 29, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 8, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 8, 2013

    LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 16, 2024

    BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·April 19, 2023

    BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·April 19, 2023

    CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·March 3, 2021

    Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

    FDA Recall
    Terminated ·Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Seocho-Daero, Seocho # 413 398 Platinum Tower Seoul Korea (the Republic of)·Product code EXY·April 21, 2022