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

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    SOZO Pro

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034005072·ISOLA SPINE SYSTEM MCC PLATE 15-30mm

    PROFILE

    FDA UDI
    Medos International Sàrl·10886705010516·PROFILE CANNULATED INTERFERENCE SCREW ROUND HEA...

    Handicare

    FDA UDI
    HANDICARE USA, INC.·00810045510200·ErgoGlide 5300

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707023227·CALIBRA BANDS 2ND MOLAR n.SUL 30

    Bow-Flex Wire

    FDA UDI
    TP ORTHODONTICS INC·00192029036051·Round ...

    AMICUS Separator System

    FDA 510(k)
    FDA Class 2 ·Hematology

    Albumin BCP2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VANGUARD TIBIAL BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 28, 2017

    BIOMET CRUCIATE TRAY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 28, 2017

    SMART CONTROL NITINOL STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code FGE·November 12, 2008

    AVAULTA PLUS SYNTHETIC SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code FTL·August 12, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 16, 2013

    VANGUARD INTERLOK FEMORAL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 28, 2017

    RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008 (01)00860003983812(11)240528(21)X11009 (01)00860003983812(11)240820(21)X11010 (01)00860003983812(11)241107(21)X11011 (01)00860003983812(11)241206(21)X11012 The RefleXion X1 is a radiation therapy system that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography detection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA cleared, authorized, or approved linear accelerator.

    FDA Enforcement
    Class II ·Ongoing·Reflexion Medical, Inc.·September 10, 2025

    RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.

    FDA Enforcement
    Class II ·Ongoing·Reflexion Medical, Inc.·June 5, 2024

    RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

    FDA Enforcement
    Class II ·Ongoing·Reflexion Medical, Inc.·April 8, 2026

    RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008 (01)00860003983812(11)240528(21)X11009 (01)00860003983812(11)240820(21)X11010 (01)00860003983812(11)241107(21)X11011 (01)00860003983812(11)241206(21)X11012 The RefleXion X1 is a radiation therapy system that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography detection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA cleared, authorized, or approved linear accelerator.

    FDA Recall
    Open, Classified ·Reflexion Medical, Inc.·Product code QVA·July 22, 2025

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017