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    Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·February 18, 2026

    Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·February 18, 2026

    Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. Medline Item Numbers 10135910RH 10135936RH

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·October 8, 2025

    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.

    FDA Enforcement
    Class II ·Ongoing·GE Hangwei Medical Systems, Co. LTD·December 20, 2023

    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.

    FDA Enforcement
    Class II ·Ongoing·GE Hangwei Medical Systems, Co. LTD·December 20, 2023

    ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040

    FDA Enforcement
    Class II ·Ongoing·PHASE SCIENTIFIC INTERNATIONAL LIMITED·January 24, 2024

    STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40

    FDA Enforcement
    Class II ·Ongoing·Contego Medical LLC·October 22, 2025

    On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

    FDA Enforcement
    Class II ·Ongoing·On-X Life Technologies, Inc.·May 20, 2026

    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.

    FDA Enforcement
    Class II ·Terminated·On-X Life Technologies, Inc.·February 1, 2017