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

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    SureMAX-SA Cervical Standalone System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205002938·Luna Opal MB Mini .018 UR4,5 D/HK (-7°T 0°A)

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551111368·HALO, 1203-5 VEST SMALL, ACRYLIC LINER, 1211-1 ...

    MISSION U500 URINE ANALYZER

    FDA UDI
    Acon Laboratories, Inc.·20682607200515·URINE ANALYZER with Barcode Reader

    EXACT QUICK CONNECT DRILL BIT

    FDA UDI
    Biomet Orthopedics, LLC·00880304607682·

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167322111110·

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946072148·SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946061142·X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LE...

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167312111110·

    ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    MAQUET/DATASCOPE

    FDA Adverse Event
    Death ·MAQUET GETINGE GROUP·Product code DSP·March 1, 2012

    iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.

    FDA Recall
    Terminated ·Conformis, Inc.·Product code JWH·December 3, 2018

    INRATIO

    FDA Adverse Event
    Injury ·HEMOSENSE, INC.·Product code JPA·October 23, 2008

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·August 5, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

    iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.

    FDA Enforcement
    Class II ·Terminated·Conformis, Inc.·April 17, 2019

    Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

    FDA Recall
    Terminated ·Conformis, Inc.·Product code JWH·July 20, 2020

    Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

    FDA Enforcement
    Class II ·Terminated·Conformis, Inc.·September 2, 2020