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

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    Macro & Micro-Test HCG Pregnancy Test Midstream

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ERCHONIA PL5000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMP,TSV,MCOL MG,3.7MM,8MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·December 19, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 1, 2021

    BUTTON REPLACEMENT GASTROSTOMY DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNT·October 28, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 1, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 17, 2022

    IMP,TSV,MCOL MG,3.7MM,8MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 18, 2022

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 5, 2021

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021