BEUDAMED
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    Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX¿ Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.

    FDA Enforcement
    Class III ·Ongoing·Trackx Technology Inc·November 6, 2024

    My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·July 9, 2025

    MOSAIQ Oncology Information System

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·August 3, 2016

    Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.

    FDA Enforcement
    Class II ·Ongoing·C.A. Greiner & Sohne Gesellschaftmbh·September 9, 2020

    GM Helix Acqua Implant, Article Number: 140.985

    FDA Enforcement
    Class II ·Ongoing·Straumann USA LLC·June 4, 2025

    GM Helix Acqua Implant, Article Number: 140.984

    FDA Enforcement
    Class II ·Ongoing·Straumann USA LLC·June 4, 2025

    Wright EVOLVE TRIAD Plate Cutter, REF 49510120

    FDA Enforcement
    Class II ·Ongoing·Wright Medical Technology, Inc.·July 20, 2022

    Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·June 21, 2023

    Intelli-C, Left side suspended Tabletop, REF: 03400010

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·June 7, 2023

    Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

    FDA Enforcement
    Class II ·Ongoing·AGFA Healthcare Corp.·December 31, 2025

    LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

    FDA Enforcement
    Class I ·Ongoing·Fresenius Kabi USA, LLC·June 10, 2026

    VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·July 5, 2023

    Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations

    FDA Enforcement
    Class II ·Ongoing·Edge Biologicals Inc·April 30, 2025

    The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·June 2, 2021

    CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-5000

    FDA Enforcement
    Class II ·Ongoing·CardioFocus, Inc.·March 19, 2025

    Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

    FDA Enforcement
    Class II ·Ongoing·Elekta Inc·September 8, 2021

    Intelli-C, Right side suspended Tabletop, REF: 03400000

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·June 7, 2023

    Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·October 1, 2025

    FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·October 6, 2021

    Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·October 6, 2021