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

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.-Littleton·January 8, 2020

    Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

    FDA Enforcement
    Class II ·Terminated·Covidien Llc·November 17, 2021

    Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·December 22, 2021

    Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.

    FDA Enforcement
    Class II ·Terminated·Ortho Solutions Inc·August 9, 2017

    Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·December 22, 2021

    Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use

    FDA Enforcement
    Class II ·Terminated·Medtronic Neurosurgery·October 3, 2018

    Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·April 30, 2014

    Proton therapy system -Proteus 235 aka Proteus Plus. 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.·May 24, 2017

    Proteus 235, Proton Therapy System

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·April 26, 2017

    Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A 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.·July 18, 2018

    Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·July 25, 2018

    Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

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

    Proteus ONE and Proteus Plus

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

    adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C 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 device.

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·December 31, 2014

    Proteus 235 Proton Therapy System for cancer treatment.

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·November 5, 2014

    Proteus 235

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·April 5, 2017

    Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

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

    Proteus 235

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·June 28, 2017

    Proteus 235 and Proteus ONE proton therapy systems

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

    Proteus 235, Proton Therapy System a medical device designed to produce and delivers 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.·March 21, 2018