BEUDAMED
    219 results · 17ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    Theratron Elite 80 Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Leksell Gamma Knife C

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·August 1, 2006

    Leksell GammaPlan 8.0 image fusion Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. the Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health professions (Neurosurgeons, Radiation therapists, Radiation Physicists) such that the desired radiation does is proved by the Leksell Gamma Knife to a precisely defined target area within the cranium.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·January 7, 2008

    GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.

    FDA Recall
    Open, Classified ·Xcision Medical Systems, LLC·Product code IWB·November 30, 2023

    Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·September 17, 2010

    Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·June 23, 2011

    Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g., metastatic tumors, recurrent glioblastomas, trigeminal neuralgia, medically refractory essential tremor, orbital tumors, ocular tumors, optic nerve tumors, benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas), skull base tumors, head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland), and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·May 23, 2017

    Theratron Phoenix Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·June 1, 2015

    Theratron 780E Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·November 6, 2009

    Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professional (Neurosurgeons, Radiation Therapists and Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·October 23, 2008

    GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.

    FDA Recall
    Terminated ·Xcision Medical Systems, LLC·Product code IWB·July 3, 2019

    Theratron 780C Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·October 1, 2005

    Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

    FDA Recall
    Open, Classified ·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code IWB·June 27, 2018

    Elekta Leksell Gamma Knife C 1.2, 4 and 4C Product Usage: Leksell Gamma Knife is a teletherapy device intended for stereotactic irradiation of head structures.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·May 26, 2011

    Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·April 19, 2016

    Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·July 2, 2007

    Theratron Elite 100 Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004