BEUDAMED
    20 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × 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

    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

    Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: DBK 027

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·October 20, 2021

    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

    ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.

    FDA Enforcement
    Class II ·Terminated·Zavation·June 9, 2021

    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

    Proteus 235 and Proteus ONE proton therapy systems

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

    Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·October 20, 2021

    Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·October 20, 2021

    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

    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

    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 The PTS 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.·June 20, 2018

    COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry Gmbh·March 4, 2015

    COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry Gmbh·November 12, 2014

    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

    BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

    FDA Enforcement
    Class II ·Terminated·B-K Medical A/S·August 10, 2016