BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    inCoris ZI

    FDA UDI
    SIRONA Dental Systems GmbH·E27662306552·inCoris ZI mono S F2 3 Stück/pcs.

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025064·T45 Warming Plate

    Sonic

    FDA UDI
    Sbo Hearing A/S·05714464032389·SONIC RADIANT 100 MNR T GR/DG

    RESPONSE SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOLOTC RIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·August 29, 2022

    LIBERTY CYCLER

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE·Product code FKX·October 27, 2014

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.Y

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

    WHEELCHAIR COMPONENTS

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code KNN·July 16, 2013

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 23, 2025

    7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEA

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·January 31, 2024

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 23, 2025

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·January 11, 2022

    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    CODMAN Disposable Perforator 11mm. Cranial Perforator.

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

    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024