BEUDAMED
    35 results · 12ms · Sources: EU EUDAMED, US FDA

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    Proteus 235 Product Usage: 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.·January 16, 2019

    Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 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 21, 2018

    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

    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 19, 2020

    Proteus 235, Proton Therapy System

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

    12C

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

    Proteus ONE and Proteus Plus

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

    AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.

    FDA Enforcement
    Class II ·Terminated·Encision, Inc.·July 18, 2012

    COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018

    COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018

    COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S

    FDA Enforcement
    Class II ·Terminated·Wilson-Cook Medical Inc.·February 6, 2019

    COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

    FDA Enforcement
    Class II ·Terminated·Wilson-Cook Medical Inc.·February 6, 2019

    Human Fetal Hemoglobin (HBF-1) FITC Conjugate

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code GHQ·February 7, 2018

    Human Fetal Hemoglobin (HBF-1) FITC Conjugate

    FDA Enforcement
    Class II ·Terminated·Life Technologies Corporation·April 25, 2018

    G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JPD·August 18, 2010

    Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown, PA 19403

    FDA Recall
    Terminated ·Skf USA Inc·July 24, 2007

    Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403

    FDA Recall
    Terminated ·Skf USA Inc·July 24, 2007

    Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000, SKF USA, Inc. Norristown, PA 19403

    FDA Recall
    Terminated ·Skf USA Inc·July 24, 2007