BEUDAMED
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    Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Waismed Ltd.·July 23, 2025

    OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.

    FDA Enforcement
    Class II ·Ongoing·LUMENIS, LTD.·August 27, 2025

    Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Waismed Ltd.·July 23, 2025

    (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.

    FDA Enforcement
    Class II ·Ongoing·LUMENIS, LTD.·March 12, 2025

    Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.

    FDA Enforcement
    Class II ·Ongoing·Augmedics Ltd.·May 21, 2025

    VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012

    FDA Enforcement
    Class II ·Ongoing·Visionsense, Ltd.·November 30, 2022

    The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.

    FDA Enforcement
    Class II ·Ongoing·FEMSelect Ltd·February 9, 2022

    VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001

    FDA Enforcement
    Class II ·Ongoing·Visionsense, Ltd.·November 30, 2022

    VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012

    FDA Enforcement
    Class II ·Ongoing·Visionsense, Ltd.·November 30, 2022

    Mazor X robotic guidance system REF: TPL0059

    FDA Enforcement
    Class II ·Ongoing·Mazor Robotics Ltd·January 28, 2026

    CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only

    FDA Enforcement
    Class II ·Ongoing·CORNEAT VISION, LTD.·September 17, 2025

    CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

    FDA Enforcement
    Class II ·Ongoing·CORNEAT VISION, LTD.·October 15, 2025

    EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202

    FDA Enforcement
    Class II ·Ongoing·CORNEAT VISION, LTD.·October 15, 2025

    TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.

    FDA Enforcement
    Class II ·Ongoing·PREMIA SPINE LTD·September 10, 2025

    Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)

    FDA Enforcement
    Class I ·Ongoing·Given Imaging Ltd.·July 16, 2025

    Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument

    FDA Enforcement
    Class II ·Ongoing·Mazor Robotics Ltd·September 25, 2024

    Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

    FDA Enforcement
    Class II ·Ongoing·SIGHT DIAGNOSTICS LTD·July 3, 2024

    OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

    FDA Enforcement
    Class II ·Ongoing·SIMPLIVIA HEALTHCARE LTD.·May 18, 2022

    IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)

    FDA Enforcement
    Class II ·Ongoing·Icecure Medical Ltd·October 11, 2023

    Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)

    FDA Enforcement
    Class I ·Ongoing·EITAN MEDICAL LTD·October 25, 2023