BEUDAMED
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    AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.

    FDA Enforcement
    Class II ·Ongoing·MRP, LLC dba Aquabiliti·February 28, 2024

    Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Technologies Ltd.·November 27, 2024

    Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.

    FDA Enforcement
    Class II ·Ongoing·Abbott·July 13, 2022

    GEO-MED CATARACT PACK, REF 89-5790.08

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·December 21, 2022

    Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.

    FDA Enforcement
    Class II ·Ongoing·Johnson & Johnson Surgical Vision, Inc.·November 9, 2022

    Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Enforcement
    Class II ·Ongoing·Nexstim PLC·June 14, 2017

    Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which is placed, during arthroplasty, in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes to meet various anatomical variations and is supplied sterile. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Osteotec Limited·August 6, 2025