BEUDAMED
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    Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.

    FDA Enforcement
    Class II ·Completed·Shimadzu Medical Systems·July 22, 2020

    Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.

    FDA Recall
    Completed ·Shimadzu Medical Systems·Product code OWB·November 4, 2019

    Revolution CT

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·July 14, 2021

    Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

    FDA Enforcement
    Class II ·Completed·Fresenius Medical Care Holdings, Inc.·November 18, 2020

    RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

    FDA Enforcement
    Class II ·Completed·Appliedvr·July 5, 2023

    CarePoint 60 mL Syringe Without Needle, REF: 04-7560

    FDA Enforcement
    Class II ·Completed·Allison Medical, Inc.·December 21, 2022

    BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

    FDA Enforcement
    Class II ·Completed·C.R. Bard Inc·March 2, 2022

    BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C

    FDA Enforcement
    Class II ·Completed·C.R. Bard Inc·March 2, 2022

    3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.

    FDA Enforcement
    Class II ·Completed·Stryker Corporation·June 13, 2018

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Enforcement
    Class II ·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Enforcement
    Class II ·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020

    VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test

    FDA Enforcement
    Class II ·Completed·Luminex Corporation·June 11, 2025

    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

    FDA Enforcement
    Class II ·Completed·Murata Vios, Inc.·January 22, 2025

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    FDA Enforcement
    Class II ·Completed·Encore Medical, Lp·April 4, 2018

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    FDA Enforcement
    Class II ·Completed·Encore Medical, Lp·April 4, 2018

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    FDA Enforcement
    Class II ·Completed·Encore Medical, Lp·April 4, 2018

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    FDA Enforcement
    Class II ·Completed·Encore Medical, Lp·April 4, 2018

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    FDA Enforcement
    Class II ·Completed·Encore Medical, Lp·April 4, 2018

    ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

    FDA Enforcement
    Class II ·Completed·Siemens Medical Solutions USA, Inc·July 4, 2018

    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

    FDA Enforcement
    Class II ·Completed·Accuray Incorporated·September 6, 2023