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

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

    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03

    FDA Enforcement
    Class II ·Ongoing·Linkbio Corp.·May 10, 2023

    Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I

    FDA Enforcement
    Class II ·Completed·Applied Medical Technology Inc·November 19, 2025

    RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.

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

    Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I

    FDA Enforcement
    Class II ·Completed·Applied Medical Technology Inc·November 19, 2025

    RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Software Version: 12.0.4.12. 5. RayStation 11B Service Pack Toshiba 1, Software Version: 12.3.0.119. Product Description: Radiation Therapy Treatment Planning System.

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

    Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A

    FDA Enforcement
    Class II ·Ongoing·American Surgical Company, LLC·November 13, 2024

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1

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

    RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System

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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021