BEUDAMED
    28 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    12C

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·June 20, 2018

    Proteus ONE and Proteus Plus

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·June 20, 2018

    IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.

    FDA Enforcement
    Class II ·Terminated·International Biophysics Corp.·August 26, 2015

    iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry Gmbh·December 18, 2013

    IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·International Biophysics Corp.·August 26, 2015

    IBA Proton Therapy System - PROTEUS 235

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

    IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.

    FDA Enforcement
    Class II ·Terminated·International Biophysics Corp.·August 26, 2015

    IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry Gmbh·January 27, 2016

    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

    Proteus 235, graphite block 8

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·March 14, 2018

    The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·July 4, 2018

    Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·June 12, 2013

    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 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

    Proteus 235 and Proteus ONE proton therapy systems

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·July 12, 2017

    Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry·June 14, 2017

    12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·June 13, 2018

    Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device 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 ·Terminated·Ion Beam Applications S.A.·August 5, 2020

    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

    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