BEUDAMED
    8 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·May 8, 2024

    HIGH V+ Spinal Cement System REF T040321K

    FDA Enforcement
    Class II ·Ongoing·TEKNIMED SAS·February 15, 2023

    RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·September 10, 2025

    Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable

    FDA Enforcement
    Class II ·Ongoing·Abbott Diagnostics Scarborough, Inc.·March 25, 2026

    RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014