BEUDAMED
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    Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

    FDA Enforcement
    Class II ·Ongoing·Zoe Medical Incorporated·September 18, 2024

    Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

    FDA Enforcement
    Class II ·Ongoing·Zoe Medical Incorporated·September 18, 2024

    IBA Proton Therapy System - PROTEUS 235

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·March 18, 2026

    IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·September 18, 2024

    IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·June 12, 2024

    Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·June 8, 2022

    IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·November 22, 2023

    IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·May 1, 2024

    ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·March 16, 2022

    Proteus 235-Proton Therapy System

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·August 4, 2021

    Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·September 15, 2021

    IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·August 28, 2024

    Lazervida 10W diode laser cutter and engraver with Lazervida shield.

    FDA Enforcement
    Class II ·Ongoing·Flux Technology Inc.·June 11, 2025

    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 Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No

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

    Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·June 28, 2023

    Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·June 28, 2023

    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

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No

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

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No

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