BEUDAMED
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    SM INTERNAL/EXTERNAL IMPLANT SYSTEMS

    FDA UDI
    DIO Corporation·08800049286937·SM Implant System is a root-form threaded denta...

    SM INTERNAL/EXTERNAL IMPLANT SYSTEMS

    FDA UDI
    DIO Corporation·08806195927281·SM Implant System is a root-form threaded denta...

    RAYSTATION

    FDA Adverse Event
    Malfunction ·RAYSEARCH LABORATORIES AB (PUBL)·Product code MUJ·March 6, 2023

    RAYSTATION

    FDA Adverse Event
    Malfunction ·RAYSEARCH LABORATORIES AB (PUBL)·Product code MUJ·March 6, 2023

    PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

    FDA Adverse Event
    Other ·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code MUJ·September 13, 2008

    PINNACLE3

    FDA Adverse Event
    Malfunction ·ADAC LABORATORIES·Product code IYE·June 23, 1999

    HOYA ISERT 150

    FDA Adverse Event
    Injury ·HOYA SURGICAL OPTICS, INC.·Product code HQL·July 19, 2021

    PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

    FDA Adverse Event
    Other ·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC·Product code MUJ·September 13, 2008

    PINNACLE3

    FDA Adverse Event
    Malfunction ·ADAC LABORATORIES·Product code IYE·September 28, 2000

    BD ONEFLOW ALOT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 10, 2021

    CS&T IVD BEADS 50TEST

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 10, 2021

    RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

    FDA Recall
    Terminated ·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·October 8, 2020

    8110 ALARIS SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 8, 2021

    STROLLER G3 PB

    FDA Adverse Event
    Other ·CAIRE, INC.·Product code BYJ·April 8, 2008

    RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·December 2, 2020

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·June 1, 2022

    BROSELOW RAINBOW TAPE

    FDA Adverse Event
    Malfunction ·SUNMED GROUP HOLDINGS, LLC DBA AIRLIFE·Product code OKI·December 10, 2025

    UNI-VENT, MODEL 731

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code CBK·April 7, 2022

    HOYA 255

    FDA Adverse Event
    Injury ·HOYA SURGICAL OPTICS, INC.·Product code HQL·August 20, 2021

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·October 29, 2024